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Poststroke Neurorehabilitation Using a Soft Robotic Glove Combined With a Virtual Environment: Preliminary Study on Feasibility, Safety, Effects, and User Satisfaction. 脑卒中后神经康复使用软机器人手套结合虚拟环境:可行性,安全性,效果和用户满意度的初步研究。
Pub Date : 2025-08-27 eCollection Date: 2025-01-01 DOI: 10.2196/69750
Camille E Proulx, Johanne Higgins, Thomas Vaughan, Mark Hewko, Dany H Gagnon
<p><strong>Background: </strong>Optimizing rehabilitation intensity using a robotic-assisted hand rehabilitation exercise (RAHRE) program coupled with a virtual environment is a promising intervention as it aligns with key neuroplasticity principles.</p><p><strong>Objective: </strong>The aim of the study is to assess the feasibility, safety, preliminary effects, and satisfaction of the 2-week RAHRE program offered as an adjunct to conventional rehabilitation.</p><p><strong>Methods: </strong>In total, 11 adults with hand hemiparesis following a recent stroke and undergoing intensive functional rehabilitation were randomized into experimental and control groups. Both groups received conventional rehabilitation therapy over a 2-week period. The experimental group received 10 additional 30-minute sessions of the RAHRE program (5 times per week), incorporating 4 hand opening and closing exercises with personalized glove assistance or resistance levels with virtual reality over the same period. Measures of feasibility (ie, attendance rate, compliance rate, repetitions per session, active training time, therapist verbal cueing, and support required), safety (ie, discomfort and adverse effects), and satisfaction (ie, satisfaction questionnaire) were collected. Functional outcomes (ie, Action Research Arm Test [ARAT], Fugl-Meyer Assessment for the Upper Extremity [FMA-UE], Box and Block Test, ABILHAND) were also assessed before and after the intervention in both groups.</p><p><strong>Results: </strong>Attendance and compliance rates in the experimental group reached 96% (48 completed training sessions of 50 planned sessions) and 95% (1432 completed training minutes of 1500 planned minutes), respectively. Participants performed a median of 2543 (IQR 2368-2951) additional movement repetitions during the RAHRE program (median repetitions per session 260, IQR 173-365; median active training time 24 minutes 39 seconds, IQR 22 minutes 26 seconds-25 minutes 51 seconds). Minimal therapist verbal cueing and support were necessary for technology use (median glove donning time 46, IQR 27-60 seconds; median independence achieved in 6, IQR 4-7 sessions). No abnormal discomfort or adverse effects were reported. Both groups showed functional improvements in ARAT, FMA-UE, Box and Block Test, and ABILHAND. For the primary outcomes (ie, ARAT and FMA-UE), the median score changes were, respectively, 4.50 (IQR 0-9) and 4.00 (IQR 3-4) in the control group, and 4.00 (IQR 1-7.5) and 5.00 (IQR 5-6) in the experimental group. Excellent overall program satisfaction (median 5/5, IQR 5-5) was reported for the RAHRE program.</p><p><strong>Conclusions: </strong>The RAHRE program, as an adjunct to conventional rehabilitation therapy, emerges as being feasible, safe, beneficial, and satisfying for adults with hand hemiparesis following a recent stroke. However, careful interpretation of the results remains recommended given the strength of the evidence. Future studies providing higher-q
背景:利用机器人辅助手部康复训练(RAHRE)程序与虚拟环境相结合来优化康复强度是一种很有前途的干预措施,因为它符合关键的神经可塑性原则。目的:本研究的目的是评估2周RAHRE方案作为常规康复辅助的可行性、安全性、初步效果和满意度。方法:将11例近期中风后手偏瘫患者随机分为实验组和对照组。两组患者均接受常规康复治疗2周。实验组接受了10次额外的30分钟的RAHRE项目(每周5次),包括4次手的打开和关闭练习,在同一时期有个性化的手套辅助或虚拟现实的阻力水平。收集可行性(即出勤率、依从率、每次重复次数、积极训练时间、治疗师口头提示和所需的支持)、安全性(即不适和不良反应)和满意度(即满意度问卷)的措施。对两组干预前后的功能结果(即动作研究臂测试[ARAT]、Fugl-Meyer上肢评估[FMA-UE]、盒块测试、ABILHAND)进行评估。结果:实验组的出勤率为96%(计划训练50次,训练完成48次),依从率为95%(计划训练1500分钟,训练完成1432分钟)。在RAHRE项目中,参与者进行了2543次(IQR 2368-2951)额外运动重复(平均每次重复260次,IQR 173-365次;平均主动训练时间24分39秒,IQR 22分26秒-25分51秒)。最少的治疗师口头提示和支持是技术使用所必需的(戴手套的平均时间为46,IQR 27-60秒;平均独立时间为6,IQR 4-7次)。未见异常不适或不良反应。两组的ARAT、FMA-UE、Box and Block Test、ABILHAND功能均有改善。主要指标(即ARAT和FMA-UE),对照组的中位评分变化分别为4.50 (IQR 0-9)和4.00 (IQR 3-4),实验组的中位评分变化分别为4.00 (IQR 1-7.5)和5.00 (IQR 5-6)。RAHRE项目总体满意度极佳(中位数为5/5,IQR为5-5)。结论:RAHRE项目作为常规康复治疗的辅助手段,对于近期中风后的手部偏瘫患者来说是可行、安全、有益且令人满意的。然而,考虑到证据的强度,仍然建议仔细解释结果。未来的研究需要提供更高质量的证据。
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引用次数: 0
Experiences of a Neurofeedback-Based Mindfulness Meditation Intervention for Migraine: Qualitative Study. 基于神经反馈的正念冥想干预偏头痛的经验:定性研究。
Pub Date : 2025-07-31 eCollection Date: 2025-01-01 DOI: 10.2196/68369
Tora Levinton, Jan Gelech, Faly Golshan, Marla Mickleborough

Background: Migraine is a debilitating neurological condition often impacting the quality of life and resulting in physical, emotional, and social burdens. Pharmaceutical interventions are the conventional treatment for migraine; however, behavioral interventions provide safe alternatives. Both mindfulness meditation and neurofeedback are behavioral interventions that have been separately studied for migraine treatment. To date, no studies have investigated neurofeedback-assisted mindfulness meditation for migraine treatment and prevention.

Objective: The objective of our study was to document the experiences of individuals with migraines who participated in an 8-week neurofeedback-based mindfulness meditation intervention as part of a randomized controlled trial.

Methods: Semistructured interviews were undertaken with 10 participants (7 female and 3 male participants) aged 23 to 55 years who had previously completed an 8-week neurofeedback-based mindfulness meditation program using Muse wearable sensory headbands as part of a randomized control trial. The interview data were analyzed using reflexive thematic analysis.

Results: Participants spoke to 3 categories of experiences: the positive impact of neurofeedback-based mindfulness meditation on migraine experiences, enhanced well-being and improved quality of life resulting from the intervention, and the benefits and drawbacks of incorporating a portable electroencephalogram technology into mindfulness meditation practices in the context of migraine treatment. In total, 9 participants felt that their ability to manage migraine symptoms was improved, and all participants expressed benefits beyond migraine prevention and pain management. Participants also spoke to the interconnectedness of migraine symptoms, daily stressors, and the framing of lived experience.

Conclusions: Notably, as the first study to evaluate the experiences of individuals with migraines using an at-home, neurofeedback-based mindfulness meditation intervention, this investigation adds to our understanding of nonpharmaceutical migraine treatment. Participants reported that this neurofeedback-based mindfulness meditation intervention improved migraine management, leading to significant reductions in pain intensity, migraine frequency, and medication use. They also described improved quality of life and emotional regulation related to this intervention, which they attributed to enhanced attentional control and body awareness. This research supports the consideration of neurofeedback-based mindfulness meditation interventions using emerging technologies, such as wearable electroencephalogram devices, as an accessible behavioral intervention for migraine management.

背景:偏头痛是一种使人衰弱的神经系统疾病,经常影响生活质量,导致身体、情感和社会负担。药物干预是偏头痛的常规治疗方法;然而,行为干预提供了安全的替代方案。正念冥想和神经反馈都是分别用于偏头痛治疗的行为干预。到目前为止,还没有研究调查神经反馈辅助的正念冥想对偏头痛的治疗和预防。目的:我们研究的目的是记录偏头痛患者参加为期8周的基于神经反馈的正念冥想干预作为随机对照试验的一部分的经历。方法:对10名年龄在23至55岁之间的参与者(7名女性和3名男性)进行半结构化访谈,这些参与者之前使用Muse可穿戴感官头带完成了为期8周的基于神经反馈的正念冥想计划,作为随机对照试验的一部分。访谈数据采用反身性主题分析法进行分析。结果:参与者谈到了三类体验:基于神经反馈的正念冥想对偏头痛体验的积极影响,干预带来的幸福感和生活质量的提高,以及在偏头痛治疗背景下将便携式脑电图技术纳入正念冥想练习的利弊。总共有9名参与者认为他们控制偏头痛症状的能力得到了改善,所有参与者都表示受益于偏头痛预防和疼痛管理。参与者还谈到了偏头痛症状、日常压力源和生活经历框架之间的相互联系。结论:值得注意的是,作为第一项评估偏头痛患者使用家庭、基于神经反馈的正念冥想干预的经验的研究,这项研究增加了我们对非药物偏头痛治疗的理解。参与者报告说,这种基于神经反馈的正念冥想干预改善了偏头痛的管理,导致疼痛强度、偏头痛频率和药物使用的显著减少。他们还描述了与这种干预相关的生活质量和情绪调节的改善,他们将其归因于注意力控制和身体意识的增强。这项研究支持考虑使用新兴技术,如可穿戴脑电图设备,以神经反馈为基础的正念冥想干预,作为偏头痛管理的一种可访问的行为干预。
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引用次数: 0
Adherence to Therapy Using Neurostimulation Devices in the Treatment of Pediatric Attention-Deficit/Hyperactivity Disorder: Extraclinical Study. 坚持使用神经刺激装置治疗儿童注意缺陷/多动障碍:临床外研究
Pub Date : 2025-07-16 eCollection Date: 2025-01-01 DOI: 10.2196/68736
Allyson Calandro, Saurabh Biswas, Anthony Guiseppi-Elie

Background: Pediatric and adolescent patients with attention-deficit/hyperactivity disorder (ADHD) present unique challenges in adherence to device-based therapies outside the clinical environment. The development, approval, and availability of neurostimulation devices for the treatment of ADHD have prompted extraclinical research (ie, outside the sphere of the clinic) on the real-world implementation of such therapies in a population that has difficulty remembering tasks and staying attentive to therapy.

Objective: This study aims to explore the extraclinical pediatric ADHD treatment environment to ensure that design considerations and stakeholder contributions to future innovations are effective.

Methods: Using the Lean LaunchPad methodology with its emphasis on customer discovery and the business model canvas, qualitative analysis methods were applied to elicit the most pertinent themes regarding ADHD treatment in children and the general perception of a new device-based treatment regimen.

Results: Stakeholders expressed a desire that, for innovative ADHD therapies to appeal to children, they include a remote adherence monitoring component and maintain strong evidence of efficacy.

Conclusions: Such barriers to access and desired design features should be strongly considered in the development of neurostimulation therapies for pediatric patients with ADHD. Pediatric and adolescent patients with ADHD require attentive device design considerations to achieve therapeutic adherence in a real-world setting.

背景:患有注意缺陷/多动障碍(ADHD)的儿童和青少年患者在临床环境之外坚持基于设备的治疗方面面临着独特的挑战。治疗多动症的神经刺激装置的发展、批准和可用性促使了临床外的研究(即在临床范围之外),即在现实世界中对有记忆任务困难和对治疗保持注意力的人群实施这种治疗。目的:本研究旨在探索儿童ADHD的临床外治疗环境,以确保设计考虑和利益相关者对未来创新的贡献是有效的。方法:采用精益LaunchPad方法,强调客户发现和商业模式画布,采用定性分析方法,引出有关儿童ADHD治疗的最相关主题,以及对基于设备的新治疗方案的一般看法。结果:利益相关者表达了一种愿望,希望创新的ADHD治疗方法能够吸引儿童,包括远程依从性监测成分,并保持强有力的疗效证据。结论:在开发针对小儿多动症患者的神经刺激疗法时,应强烈考虑这些获取障碍和期望的设计特征。儿童和青少年多动症患者需要细心的设备设计考虑,以实现治疗依从性在现实世界的设置。
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引用次数: 0
Reduction of Anxiety-Related Symptoms Using Low-Intensity Ultrasound Neuromodulation on the Auricular Branch of the Vagus Nerve: Preliminary Study. 低强度超声神经调节迷走神经耳支减轻焦虑相关症状的初步研究
Pub Date : 2025-05-01 eCollection Date: 2025-01-01 DOI: 10.2196/69770
Izzy Kohler, Jon Hacker, Ethan Martin

Background: Neuromodulation of the auricular branch of the vagus nerve using low-intensity focused ultrasound (LIFU) is an emerging mode of treatment for anxiety that could provide a complementary or alternative treatment modality for individuals who are refractory to conventional interventions. The proposed benefits of this technology have been largely unexamined with clinical populations. Further research is required to understand its clinical potential and use in improving and managing moderate to severe symptoms.

Objectives: The aim of this study was to do a preliminary investigation into the efficacy, safety, and usability of the wearable headset that delivers LIFU to the auricular branch of the vagus nerve for the purpose of alleviating anxiety disorder symptoms.

Methods: This study was a pre-post intervention study design for which we recruited 28 participants with a Beck Anxiety Inventory score of 16 points or greater. Participants completed 5 minutes of treatment daily consisting of LIFU neuromodulation delivered to the auricular branch of the vagus nerve. Participants did this for a period of 4 weeks. Assessments of anxiety symptom severity (Beck Anxiety Inventory), depression symptom severity (Beck Depression Inventory), posttraumatic stress disorder symptom severity (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]), and sleep quality (Pittsburgh Sleep Quality Index) were taken prior to starting treatment and weekly for 4 weeks of treatment. Usability and safety were also assessed using an exit questionnaire and adverse event logging.

Results: After completing 4 weeks of LIFU neuromodulation to the auricular branch of the vagus nerve, the average Beck Anxiety Inventory score decreased by 14.9 (SD 10.6) points (Cohen d=1.06; P<.001), the average Beck Depression Inventory score decreased by 10.3 (SD 7.8) points (Cohen d=0.81; P<.001), the average Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) score decreased by 20.0 (SD 20.5) points (Cohen d=0.94; P<.001), and the average Pittsburgh Sleep Quality Index score decreased by 2.2 (SD 3.1) points (Cohen d=0.65; P=.001). On the exit questionnaire, participants rated the treatment highly for ease of use, effectiveness, and worthiness of the time invested. Only 1 adverse event was reported throughout the entire trial, which was mild and temporary.

Conclusions: This preliminary study provided justification for further research into the efficacy, safety, and feasibility of using LIFU to modulate the auricular branch of the vagus nerve and reduce the symptoms of anxiety, depression, and posttraumatic stress disorder.

背景:使用低强度聚焦超声(LIFU)对迷走神经耳支进行神经调节是一种新兴的焦虑治疗模式,可以为难以接受常规干预的个体提供补充或替代治疗方式。这项技术的益处在很大程度上没有经过临床人群的检验。需要进一步研究以了解其临床潜力以及在改善和管理中度至重度症状方面的用途。目的:本研究的目的是对可穿戴式耳机的有效性、安全性和可用性进行初步调查,该耳机将LIFU输送到迷走神经耳支,以减轻焦虑障碍症状。方法:本研究采用干预前后研究设计,我们招募了28名贝克焦虑量表得分为16分或更高的参与者。参与者每天完成5分钟的治疗,包括传递给迷走神经耳支的LIFU神经调节。参与者这样做了4周。治疗开始前和治疗4周后,每周进行焦虑症状严重程度(贝克焦虑量表)、抑郁症状严重程度(贝克抑郁量表)、创伤后应激障碍症状严重程度(精神障碍诊断与统计手册[第五版]创伤后应激障碍检查表)和睡眠质量(匹兹堡睡眠质量指数)评估。可用性和安全性也通过退出问卷和不良事件记录进行评估。结果:完成4周的LIFU神经调节迷走神经耳支后,Beck焦虑量表评分平均下降14.9分(SD 10.6)分(Cohen d=1.06; Pd=0.81;《精神障碍诊断与统计手册(第五版)》评分平均下降20.0分(SD 20.5)分(Cohen d=0.94; Pd=0.65; P= 0.001)。在退出问卷中,参与者对治疗的易用性、有效性和投入时间的价值给予了很高的评价。在整个试验过程中,仅报告了1例轻微和暂时的不良事件。结论:本初步研究为进一步研究LIFU调节迷走神经耳支,减轻焦虑、抑郁和创伤后应激障碍症状的有效性、安全性和可行性提供了依据。
{"title":"Reduction of Anxiety-Related Symptoms Using Low-Intensity Ultrasound Neuromodulation on the Auricular Branch of the Vagus Nerve: Preliminary Study.","authors":"Izzy Kohler, Jon Hacker, Ethan Martin","doi":"10.2196/69770","DOIUrl":"10.2196/69770","url":null,"abstract":"<p><strong>Background: </strong>Neuromodulation of the auricular branch of the vagus nerve using low-intensity focused ultrasound (LIFU) is an emerging mode of treatment for anxiety that could provide a complementary or alternative treatment modality for individuals who are refractory to conventional interventions. The proposed benefits of this technology have been largely unexamined with clinical populations. Further research is required to understand its clinical potential and use in improving and managing moderate to severe symptoms.</p><p><strong>Objectives: </strong>The aim of this study was to do a preliminary investigation into the efficacy, safety, and usability of the wearable headset that delivers LIFU to the auricular branch of the vagus nerve for the purpose of alleviating anxiety disorder symptoms.</p><p><strong>Methods: </strong>This study was a pre-post intervention study design for which we recruited 28 participants with a Beck Anxiety Inventory score of 16 points or greater. Participants completed 5 minutes of treatment daily consisting of LIFU neuromodulation delivered to the auricular branch of the vagus nerve. Participants did this for a period of 4 weeks. Assessments of anxiety symptom severity (Beck Anxiety Inventory), depression symptom severity (Beck Depression Inventory), posttraumatic stress disorder symptom severity (Post Traumatic Stress Disorder Checklist for the <i>Diagnostic and Statistical Manual of Mental Disorders</i> [Fifth Edition]), and sleep quality (Pittsburgh Sleep Quality Index) were taken prior to starting treatment and weekly for 4 weeks of treatment. Usability and safety were also assessed using an exit questionnaire and adverse event logging.</p><p><strong>Results: </strong>After completing 4 weeks of LIFU neuromodulation to the auricular branch of the vagus nerve, the average Beck Anxiety Inventory score decreased by 14.9 (SD 10.6) points (Cohen <i>d</i>=1.06; <i>P</i><.001), the average Beck Depression Inventory score decreased by 10.3 (SD 7.8) points (Cohen <i>d</i>=0.81; <i>P</i><.001), the average Post Traumatic Stress Disorder Checklist for the <i>Diagnostic and Statistical Manual of Mental Disorders</i> (Fifth Edition) score decreased by 20.0 (SD 20.5) points (Cohen <i>d</i>=0.94; <i>P</i><.001), and the average Pittsburgh Sleep Quality Index score decreased by 2.2 (SD 3.1) points (Cohen <i>d</i>=0.65; <i>P</i>=.001). On the exit questionnaire, participants rated the treatment highly for ease of use, effectiveness, and worthiness of the time invested. Only 1 adverse event was reported throughout the entire trial, which was mild and temporary.</p><p><strong>Conclusions: </strong>This preliminary study provided justification for further research into the efficacy, safety, and feasibility of using LIFU to modulate the auricular branch of the vagus nerve and reduce the symptoms of anxiety, depression, and posttraumatic stress disorder.</p>","PeriodicalId":73555,"journal":{"name":"JMIR neurotechnology","volume":"4 ","pages":"e69770"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12671299/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145672950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness of Artificial Intelligence-Based Platform in Administering Therapies for Children With Autism Spectrum Disorder: 12-Month Observational Study. 基于人工智能的平台对自闭症谱系障碍儿童进行治疗的有效性:12个月的观察研究。
Pub Date : 2025-04-28 eCollection Date: 2025-01-01 DOI: 10.2196/70589
Harini Atturu, Somasekhar Naraganti, Bugatha Rajvir Rao
<p><strong>Background: </strong>A 12-month longitudinal observational study was conducted on 43 children aged 2-18 years to evaluate the effectiveness of the CognitiveBotics artificial intelligence (AI)-based platform in conjunction with continuous therapy in improving therapeutic outcomes for children with autism spectrum disorder (ASD).</p><p><strong>Objective: </strong>This study evaluates the CognitiveBotics software's effectiveness in supporting children with ASD through structured, technology-assisted learning. The primary objectives include assessing user engagement, tracking progress, and measuring efficacy using standardized clinical assessments.</p><p><strong>Methods: </strong>A 12-month observational study was conducted on children diagnosed with ASD using the CognitiveBotics AI-based platform. Standardized assessments, include the Childhood Autism Rating Scale (CARS), Vineland Social Maturity Scale, Developmental Screening Test, and Receptive Expressive Emergent Language Test (REEL), were conducted at baseline (T1) and at the endpoint (T2). All participants meeting the inclusion criteria were provided access to the platform and received standard therapy. Participants who consistently adhered to platform use as per the study protocol were classified as the intervention group, while those who did not maintain continuous platform use were designated as the control group. Additionally, caregivers received structured training, including web-based parent teaching sessions, reinforcement strategy training, and home-based activity guidance.</p><p><strong>Results: </strong>Participants in the intervention group demonstrated statistically significant improvements across multiple scales. CARS scores reduced from 33.41 (SD 1.89) at T1 to 28.34 (SD 3.80) at T2 (<i>P</i><.001). Social age increased from 22.80 (SD 7.33) to 35.76 (SD 9.09; mean change: 12.96, 56.84% increase; <i>P</i><.001). Social quotient increased from 53.26 (SD 11.84) to 64.75 (SD 16.12; mean change: 11.49, 21.57% increase; <i>P</i><.001). Developmental age showed an improvement from 30.93 (SD 9.91) to 45.31 (SD 11.20; mean change: 14.38, 46.49% increase; <i>P</i><.001), while developmental quotient increased from 70.94 (SD 10.95) to 81.33 (SD 16.85; mean change: 10.39, 14.65% increase; <i>P</i><.001). REEL scores showed substantial improvements, with receptive language increasing by 56.22% (<i>P</i><.001) and expressive language by 59.93% (<i>P</i><.001). In the control group, while most psychometric parameters showed some improvements, they were not statistically significant. CARS scores decreased by 10.62% (<i>P</i>=.06), social age increased by 52.27% (<i>P</i>=.06), social quotient increased by 19.62% (<i>P</i>=.12), developmental age increased by 44.88% (<i>P</i>=.06), and developmental quotient increased by 11.23% (<i>P</i>=.19). REEL receptive and expressive language increased by 34.69% (<i>P</i>=.10) and 40.48% (<i>P</i>=.054), respectively.</p><p><strong>Conclusions: </
背景:对43名2-18岁儿童进行了一项为期12个月的纵向观察研究,以评估基于CognitiveBotics人工智能(AI)平台结合持续治疗改善自闭症谱系障碍(ASD)儿童治疗结果的有效性。目的:本研究评估CognitiveBotics软件通过结构化、技术辅助学习支持ASD儿童的有效性。主要目标包括评估用户参与度、跟踪进度以及使用标准化临床评估来衡量疗效。方法:采用CognitiveBotics人工智能平台对诊断为ASD的儿童进行为期12个月的观察性研究。在基线(T1)和终点(T2)分别进行标准化评估,包括儿童自闭症评定量表(CARS)、Vineland社会成熟度量表、发育筛选测试和接受性表达性突发语言测试(REEL)。所有符合纳入标准的参与者均可进入平台并接受标准治疗。按照研究方案持续坚持使用平台的参与者被归类为干预组,而没有持续使用平台的参与者被指定为对照组。此外,护理人员还接受了结构化的培训,包括基于网络的家长教学课程、强化策略培训和家庭活动指导。结果:干预组的参与者在多个尺度上表现出统计学上显著的改善。CARS评分从T1时的33.41分(SD 1.89)降至T2时的28.34分(SD 3.80) (PPPPPPPP=.06),社会年龄提高了52.27% (P=.06),社会商提高了19.62% (P=.12),发育年龄提高了44.88% (P=.06),发育商提高了11.23% (P=.19)。REEL的接受性和表达性语言分别提高了34.69% (P= 0.10)和40.48% (P= 0.054)。结论:总体而言,该平台是提高ASD儿童治疗效果的有效补充。这个平台有望成为一种有价值的工具,可以在认知、社会和发育领域增强ASD的治疗。未来的开发应优先考虑扩大产品的跨语言可访问性,确保文化敏感性和增强用户友好性。
{"title":"Effectiveness of Artificial Intelligence-Based Platform in Administering Therapies for Children With Autism Spectrum Disorder: 12-Month Observational Study.","authors":"Harini Atturu, Somasekhar Naraganti, Bugatha Rajvir Rao","doi":"10.2196/70589","DOIUrl":"10.2196/70589","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;A 12-month longitudinal observational study was conducted on 43 children aged 2-18 years to evaluate the effectiveness of the CognitiveBotics artificial intelligence (AI)-based platform in conjunction with continuous therapy in improving therapeutic outcomes for children with autism spectrum disorder (ASD).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study evaluates the CognitiveBotics software's effectiveness in supporting children with ASD through structured, technology-assisted learning. The primary objectives include assessing user engagement, tracking progress, and measuring efficacy using standardized clinical assessments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A 12-month observational study was conducted on children diagnosed with ASD using the CognitiveBotics AI-based platform. Standardized assessments, include the Childhood Autism Rating Scale (CARS), Vineland Social Maturity Scale, Developmental Screening Test, and Receptive Expressive Emergent Language Test (REEL), were conducted at baseline (T1) and at the endpoint (T2). All participants meeting the inclusion criteria were provided access to the platform and received standard therapy. Participants who consistently adhered to platform use as per the study protocol were classified as the intervention group, while those who did not maintain continuous platform use were designated as the control group. Additionally, caregivers received structured training, including web-based parent teaching sessions, reinforcement strategy training, and home-based activity guidance.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Participants in the intervention group demonstrated statistically significant improvements across multiple scales. CARS scores reduced from 33.41 (SD 1.89) at T1 to 28.34 (SD 3.80) at T2 (&lt;i&gt;P&lt;/i&gt;&lt;.001). Social age increased from 22.80 (SD 7.33) to 35.76 (SD 9.09; mean change: 12.96, 56.84% increase; &lt;i&gt;P&lt;/i&gt;&lt;.001). Social quotient increased from 53.26 (SD 11.84) to 64.75 (SD 16.12; mean change: 11.49, 21.57% increase; &lt;i&gt;P&lt;/i&gt;&lt;.001). Developmental age showed an improvement from 30.93 (SD 9.91) to 45.31 (SD 11.20; mean change: 14.38, 46.49% increase; &lt;i&gt;P&lt;/i&gt;&lt;.001), while developmental quotient increased from 70.94 (SD 10.95) to 81.33 (SD 16.85; mean change: 10.39, 14.65% increase; &lt;i&gt;P&lt;/i&gt;&lt;.001). REEL scores showed substantial improvements, with receptive language increasing by 56.22% (&lt;i&gt;P&lt;/i&gt;&lt;.001) and expressive language by 59.93% (&lt;i&gt;P&lt;/i&gt;&lt;.001). In the control group, while most psychometric parameters showed some improvements, they were not statistically significant. CARS scores decreased by 10.62% (&lt;i&gt;P&lt;/i&gt;=.06), social age increased by 52.27% (&lt;i&gt;P&lt;/i&gt;=.06), social quotient increased by 19.62% (&lt;i&gt;P&lt;/i&gt;=.12), developmental age increased by 44.88% (&lt;i&gt;P&lt;/i&gt;=.06), and developmental quotient increased by 11.23% (&lt;i&gt;P&lt;/i&gt;=.19). REEL receptive and expressive language increased by 34.69% (&lt;i&gt;P&lt;/i&gt;=.10) and 40.48% (&lt;i&gt;P&lt;/i&gt;=.054), respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/","PeriodicalId":73555,"journal":{"name":"JMIR neurotechnology","volume":"4 ","pages":"e70589"},"PeriodicalIF":0.0,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12671327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145672819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving Alzheimer Disease Diagnosis via a Custom Convolutional Neural Network and Pretrained Models: Development and Evaluation of a Diagnostic Tool (NeuroFusionNet). 通过自定义卷积神经网络和预训练模型改进阿尔茨海默病诊断:诊断工具的开发和评估(NeuroFusionNet)。
Pub Date : 2025-03-24 eCollection Date: 2025-01-01 DOI: 10.2196/68839
Abraham Varghese, Andres Ricaurte Fajardo, Prasanth Gowda Parameshwara, Manesh Thankappan, Balakrishnan Kannan

Background: Alzheimer disease (AD) is a progressive neurodegenerative disorder that impairs cognitive function, memory, and behavior. Early and accurate diagnosis is essential for effective management; however, traditional cognitive tests often lack the sensitivity and specificity required for early detection.

Objective: This study aims to develop and evaluate NeuroFusionNet-a diagnostic tool that integrates a custom convolutional neural network (CNN) with a pretrained VGG16 model-to improve the accuracy and reliability of AD diagnosis from neuroimaging data across multiple cognitive classes.

Methods: A comprehensive preprocessing pipeline, including brain region segmentation, was implemented to isolate regions of interest and reduce noise. NeuroFusionNet extracts multilevel features by combining a custom CNN with VGG16, while Local Interpretable Model-Agnostic Explanations enhances interpretability. Data were obtained from the Alzheimer's Disease Neuroimaging Initiative database, comprising 600 test samples (120 per class for AD, cognitively normal, early mild cognitive impairment, late mild cognitive impairment, and mild cognitive impairment). Given the multiclass nature of the study, odds ratios were not applied. Statistical significance was assessed using the McNemar test for paired predictions.

Results: NeuroFusionNet achieved an overall accuracy of 0.81 (95% CI 0.779-0.841; P<.001). Per-class performance metrics were as follows: AD: precision 0.90 (95% CI 0.85-0.95), recall 0.78 (95% CI 0.72-0.84), F 1-score 0.84; cognitively normal: precision 0.67 (95% CI 0.60-0.74), recall 0.97 (95% CI 0.94-1.00), F 1-score 0.79; early mild cognitive impairment: precision 0.90 (95% CI 0.84-0.96), recall 0.82 (95% CI 0.76-0.88), F 1-score 0.86; late mild cognitive impairment: precision 0.95 (95% CI 0.90-1.00), recall 0.87 (95% CI 0.81-0.93), F 1-score 0.90; and mild cognitive impairment: precision 0.71 (95% CI 0.64-0.78), recall 0.61 (95% CI 0.53-0.69), F 1-score 0.65. Training and validation curves over 50 epochs indicated robust learning with minimal overfitting.

Conclusions: NeuroFusionNet demonstrated robust performance in a multiclass diagnostic setting, achieving high accuracy and balanced per-class performance. The combination of a custom CNN and fine-tuned VGG16, along with the interpretability provided by Local Interpretable Model-Agnostic Explanations, yields a reliable tool for early AD detection with significant potential to enhance clinical decision-making. Further validation on larger datasets is warranted.

背景:阿尔茨海默病(AD)是一种进行性神经退行性疾病,损害认知功能、记忆和行为。早期和准确的诊断是有效管理的必要条件;然而,传统的认知测试往往缺乏早期检测所需的敏感性和特异性。目的:本研究旨在开发和评估neurofusionnet -一种集成了自定义卷积神经网络(CNN)和预训练VGG16模型的诊断工具-以提高跨多个认知类别的神经影像学数据诊断AD的准确性和可靠性。方法:采用包括脑区分割在内的综合预处理流程,隔离感兴趣的区域,降低噪声。NeuroFusionNet通过结合自定义CNN和VGG16提取多层特征,而局部可解释的模型不可知论解释增强了可解释性。数据来自阿尔茨海默病神经影像学倡议数据库,包括600个测试样本(AD、认知正常、早期轻度认知障碍、晚期轻度认知障碍和轻度认知障碍每类120个)。考虑到该研究的多类别性质,比值比未被应用。使用配对预测的McNemar检验评估统计显著性。结果:NeuroFusionNet的总体准确率为0.81 (95% CI 0.779-0.841; PF 1评分0.84;认知正常:准确率0.67 (95% CI 0.60-0.74),召回率0.97 (95% CI 0.94-1.00), f1评分0.79;早期轻度认知障碍:准确率0.90 (95% CI 0.84 ~ 0.96),召回率0.82 (95% CI 0.76 ~ 0.88), f1评分0.86;晚期轻度认知障碍:准确率0.95 (95% CI 0.90 ~ 1.00),召回率0.87 (95% CI 0.81 ~ 0.93), f1评分0.90;轻度认知障碍:准确率0.71 (95% CI 0.64-0.78),召回率0.61 (95% CI 0.53-0.69), f1评分0.65。超过50个epoch的训练和验证曲线显示了最小过拟合的鲁棒学习。结论:NeuroFusionNet在多类别诊断设置中表现出强大的性能,实现了高准确性和平衡的每类别性能。自定义CNN和微调VGG16的结合,以及本地可解释模型不可知论解释提供的可解释性,产生了早期AD检测的可靠工具,具有增强临床决策的重大潜力。需要在更大的数据集上进一步验证。
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引用次数: 0
A Game-Based Mechatronic Device for Digital Rehabilitation of Hand Function After a Stroke: Design, Prototyping, and Feasibility Study. 一种基于游戏的用于中风后手部功能数字康复的机电设备:设计、原型制作和可行性研究。
Pub Date : 2025-03-19 eCollection Date: 2025-01-01 DOI: 10.2196/67779
Anuprita Kanitkar, Nariman Sepehri, Ariel Lezen, Sanjay Tejraj Parmar, Cherry Kit-Fong Hin, Tony Joseph Szturm

Background: This paper presents an easy-to-use, affordable robotic manipulandum device (RMD) equipped with smart monitoring and assistive technologies to engage in game-based exercise and repetitive task practice. The RMD has been designed to enhance a wide range of fine motor manual dexterity skills, including thumb, finger, and wrist movements. By focusing on finger and hand functions, it extends its utility beyond basic reaching or object transfer movements. Various interchangeable 3D-printed therapy handles of different shapes and sizes can be easily attached to the RMD drive shaft. These handle movements can be used to engage with numerous affordable, commercially available computer games, allowing patients to practice tasks that involve varying movement amplitudes, speeds, precision, and cognitive challenges. Additionally, the device is capable of automatically recording and storing the patient's real-time performance data on any given computer, integrating assessment into treatment.

Objective: A pilot study was conducted with 5 patients with stroke to examine the feasibility and benefits of a 6-week game-based exercise program using the proposed device.

Methods: A feasibility study was conducted with 5 participants. Data were collected using the computer game-based upper extremity assessment of manual dexterity and Wolf Motor Function Test (WMFT) before and after the intervention lasting 6 weeks.

Results: The pilot study demonstrated that clients' expectations related to manual dexterity were met. The average improvement in the functional ability score of the WMFT was 14 (SD 3) points, with all participants exceeding the minimal clinically important difference. The average reduction in total time was 30 (SD 14) seconds, with 4 of 5 participants surpassing the minimal clinically important difference. For the computer game-based upper extremity assessment, the average improvement in success rate was 23% (SD 12%), and the average decrease in response time was 105 (SD 44) milliseconds.

Conclusions: Findings revealed acceptable, engaging, game-based, and task-oriented training with a high level of compliance. Substantial improvements from pre- to postintervention were observed using the WMFT and assessments of manual dexterity.

背景:本文介绍了一种易于使用,价格合理的机器人操纵装置(RMD),配备智能监控和辅助技术,用于基于游戏的练习和重复任务练习。该RMD已被设计用于提高范围广泛的精细运动的灵巧性技能,包括拇指,手指和手腕的运动。通过专注于手指和手的功能,它扩展了它的实用性,超越了基本的到达或物体转移运动。各种可互换的不同形状和大小的3d打印治疗手柄可以很容易地连接到RMD驱动轴。这些手柄运动可以用于参与许多价格合理的商业电脑游戏,允许患者练习涉及不同运动幅度,速度,精度和认知挑战的任务。此外,该设备能够在任何给定的计算机上自动记录和存储患者的实时表现数据,将评估整合到治疗中。目的:对5例脑卒中患者进行了一项试点研究,以检验使用所提出的设备进行为期6周的基于游戏的锻炼计划的可行性和益处。方法:对5名受试者进行可行性研究。采用电脑游戏上肢手灵巧度评估和Wolf运动功能测试(WMFT)收集干预前后6周的数据。结果:初步研究表明,客户对手灵巧性的期望得到了满足。WMFT功能能力评分的平均改善为14 (SD 3)分,所有参与者都超过了最小临床重要差异。总时间的平均减少为30 (SD 14)秒,5名参与者中有4名超过了最小临床重要差异。对于基于电脑游戏的上肢评估,成功率的平均提高为23% (SD 12%),反应时间的平均减少为105毫秒(SD 44)。结论:研究结果显示,可接受的、引人入胜的、基于游戏的、以任务为导向的训练具有很高的依从性。从干预前到干预后,使用WMFT和手灵巧度评估观察到实质性的改善。
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引用次数: 0
Exploring Speech Biosignatures for Traumatic Brain Injury and Neurodegeneration: Pilot Machine Learning Study. 探索创伤性脑损伤和神经变性的语音生物特征:试点机器学习研究。
Pub Date : 2025-02-12 eCollection Date: 2025-01-01 DOI: 10.2196/64624
Rahmina Rubaiat, John Michael Templeton, Sandra L Schneider, Upeka De Silva, Samaneh Madanian, Christian Poellabauer

Background: Speech features are increasingly linked to neurodegenerative and mental health conditions, offering the potential for early detection and differentiation between disorders. As interest in speech analysis grows, distinguishing between conditions becomes critical for reliable diagnosis and assessment.

Objective: This pilot study explores speech biosignatures in two distinct neurodegenerative conditions: (1) mild traumatic brain injuries (eg, concussions) and (2) Parkinson disease (PD) as the neurodegenerative condition.

Methods: The study included speech samples from 235 participants (97 concussed and 94 age-matched healthy controls, 29 PD and 15 healthy controls) for the PaTaKa test and 239 participants (91 concussed and 104 healthy controls, 29 PD and 15 healthy controls) for the Sustained Vowel (/ah/) test. Age-matched healthy controls were used. Young age-matched controls were used for concussion and respective age-matched controls for neurodegenerative participants (15 healthy samples for both tests). Data augmentation with noise was applied to balance small datasets for neurodegenerative and healthy controls. Machine learning models (support vector machine, decision tree, random forest, and Extreme Gradient Boosting) were employed using 37 temporal and spectral speech features. A 5-fold stratified cross-validation was used to evaluate classification performance.

Results: For the PaTaKa test, classifiers performed well, achieving F 1-scores above 0.9 for concussed versus healthy and concussed versus neurodegenerative classifications across all models. Initial tests using the original dataset for neurodegenerative versus healthy classification yielded very poor results, with F 1-scores below 0.2 and accuracy under 30% (eg, below 12 out of 44 correctly classified samples) across all models. This underscored the need for data augmentation, which significantly improved performance to 60%-70% (eg, 26-31 out of 44 samples) accuracy. In contrast, the Sustained Vowel test showed mixed results; F 1-scores remained high (more than 0.85 across all models) for concussed versus neurodegenerative classifications but were significantly lower for concussed versus healthy (0.59-0.62) and neurodegenerative versus healthy (0.33-0.77), depending on the model.

Conclusions: This study highlights the potential of speech features as biomarkers for neurodegenerative conditions. The PaTaKa test exhibited strong discriminative ability, especially for concussed versus neurodegenerative and concussed versus healthy tasks, whereas challenges remain for neurodegenerative versus healthy classification. These findings emphasize the need for further exploration of speech-based tools for differential diagnosis and early identification in neurodegenerative health.

背景:言语特征越来越多地与神经退行性和精神健康状况联系在一起,为早期发现和区分疾病提供了潜力。随着人们对语音分析兴趣的增长,区分不同的情况对于可靠的诊断和评估变得至关重要。目的:本初步研究探讨两种不同神经退行性疾病的语音生物特征:(1)轻度创伤性脑损伤(如脑震荡)和(2)帕金森病(PD)作为神经退行性疾病。方法:研究包括235名参与者(97名脑震荡患者和94名年龄匹配的健康对照,29名帕金森病患者和15名健康对照)的语音样本用于PaTaKa测试,239名参与者(91名脑震荡患者和104名健康对照,29名帕金森病患者和15名健康对照)的语音样本用于持续元音(/ah/)测试。使用年龄匹配的健康对照。年轻的年龄匹配的对照组用于脑震荡和相应的年龄匹配的对照组用于神经退行性疾病参与者(两个测试中有15个健康样本)。应用噪声数据增强来平衡神经退行性和健康对照的小数据集。机器学习模型(支持向量机、决策树、随机森林和极端梯度增强)使用了37个时间和频谱语音特征。采用5次分层交叉验证来评估分类性能。结果:对于PaTaKa测试,分类器表现良好,在所有模型中,脑震荡与健康、脑震荡与神经退行性分类的f1得分均高于0.9。使用原始数据集进行神经退行性与健康分类的初始测试产生了非常差的结果,所有模型的f1得分低于0.2,准确率低于30%(例如,在44个正确分类的样本中低于12个)。这强调了对数据增强的需求,这将显著提高性能到60%-70%(例如,44个样本中的26-31个)的准确性。相比之下,持续元音测试显示了不同的结果;根据不同的模型,脑震荡与神经退行性分类的f1得分仍然很高(在所有模型中均大于0.85),但脑震荡与健康(0.59-0.62)和神经退行性分类与健康(0.33-0.77)的f1得分明显较低。结论:这项研究强调了语言特征作为神经退行性疾病生物标志物的潜力。PaTaKa测试显示出较强的区分能力,特别是震荡与神经退行性和震荡与健康任务,而神经退行性与健康分类仍然存在挑战。这些发现强调需要进一步探索基于语音的工具来鉴别诊断和早期识别神经退行性健康。
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引用次数: 0
Twenty-Five Years of AI in Neurology: The Journey of Predictive Medicine and Biological Breakthroughs. 人工智能在神经学领域的25年:预测医学和生物学突破之旅。
Pub Date : 2024-11-08 eCollection Date: 2024-01-01 DOI: 10.2196/59556
Barak Gutman, Amit-Haim Shmilovitch, Dvir Aran, Shahar Shelly

Neurological disorders are the leading cause of physical and cognitive disability across the globe, currently affecting up to 15% of the world population, with the burden of chronic neurodegenerative diseases having doubled over the last 2 decades. Two decades ago, neurologists relying solely on clinical signs and basic imaging faced challenges in diagnosis and treatment. Today, the integration of artificial intelligence (AI) and bioinformatic methods is changing this landscape. This paper explores this transformative journey, emphasizing the critical role of AI in neurology, aiming to integrate a multitude of methods and thereby enhance the field of neurology. Over the past 25 years, integrating biomedical data science into medicine, particularly neurology, has fundamentally transformed how we understand, diagnose, and treat neurological diseases. Advances in genomics sequencing, the introduction of new imaging methods, the discovery of novel molecular biomarkers for nervous system function, a comprehensive understanding of immunology and neuroimmunology shaping disease subtypes, and the advent of advanced electrophysiological recording methods, alongside the digitalization of medical records and the rise of AI, all led to an unparalleled surge in data within neurology. In addition, telemedicine and web-based interactive health platforms, accelerated by the COVID-19 pandemic, have become integral to neurology practice. The real-world impact of these advancements is evident, with AI-driven analysis of imaging and genetic data leading to earlier and more accurate diagnoses of conditions such as multiple sclerosis, Parkinson disease, amyotrophic lateral sclerosis, Alzheimer disease, and more. Neuroinformatics is the key component connecting all these advances. By harnessing the power of IT and computational methods to efficiently organize, analyze, and interpret vast datasets, we can extract meaningful insights from complex neurological data, contributing to a deeper understanding of the intricate workings of the brain. In this paper, we describe the large-scale datasets that have emerged in neurology over the last 25 years and showcase the major advancements made by integrating these datasets with advanced neuroinformatic approaches for the diagnosis and treatment of neurological disorders. We further discuss challenges in integrating AI into neurology, including ethical considerations in data use, the need for further personalization of treatment, and embracing new emerging technologies like quantum computing. These developments are shaping a future where neurological care is more precise, accessible, and tailored to individual patient needs. We believe further advancements in AI will bridge traditional medical disciplines and cutting-edge technology, navigating the complexities of neurological data and steering medicine toward a future of more precise, accessible, and patient-centric health care.

神经系统疾病是全球身体和认知残疾的主要原因,目前影响到世界人口的15%,慢性神经退行性疾病的负担在过去20年中翻了一番。二十年前,仅依靠临床体征和基本影像学的神经科医生在诊断和治疗方面面临挑战。如今,人工智能(AI)和生物信息学方法的融合正在改变这一格局。本文探讨了这一变革之旅,强调了人工智能在神经病学中的关键作用,旨在整合多种方法,从而增强神经病学领域。在过去的25年里,将生物医学数据科学融入医学,特别是神经病学,已经从根本上改变了我们理解、诊断和治疗神经系统疾病的方式。基因组测序的进步,新成像方法的引入,神经系统功能新分子生物标志物的发现,对免疫学和神经免疫学塑造疾病亚型的全面了解,先进电生理记录方法的出现,以及医疗记录的数字化和人工智能的兴起,所有这些都导致了神经学领域空前的数据激增。此外,远程医疗和基于网络的互动医疗平台,在COVID-19大流行的推动下,已成为神经病学实践不可或缺的一部分。这些进步对现实世界的影响是显而易见的,人工智能驱动的成像和基因数据分析可以更早、更准确地诊断多发性硬化症、帕金森病、肌萎缩侧索硬化症、阿尔茨海默病等疾病。神经信息学是连接所有这些进步的关键组成部分。通过利用IT和计算方法的力量来有效地组织、分析和解释大量数据集,我们可以从复杂的神经学数据中提取有意义的见解,有助于更深入地了解大脑的复杂运作。在这篇论文中,我们描述了在过去的25年里神经学中出现的大规模数据集,并展示了通过将这些数据集与先进的神经信息学方法集成在神经系统疾病的诊断和治疗中所取得的主要进展。我们进一步讨论了将人工智能整合到神经学中的挑战,包括数据使用中的伦理考虑,进一步个性化治疗的需求,以及拥抱量子计算等新兴技术。这些发展正在塑造一个神经护理更加精确、更容易获得、更适合个体患者需求的未来。我们相信,人工智能的进一步发展将在传统医学学科和尖端技术之间架起桥梁,驾驭神经学数据的复杂性,并引导医学走向更精确、更容易获得、更以患者为中心的医疗保健的未来。
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引用次数: 0
Validity of a Smartphone App to Objectively Monitor Performance Outcomes in Degenerative Cervical Myelopathy: Preliminary Findings From a Longitudinal Observational Study. 智能手机应用程序客观监测退行性颈椎病表现结果的有效性:一项纵向观察研究的初步结果
Pub Date : 2024-09-09 eCollection Date: 2024-01-01 DOI: 10.2196/52832
Alvaro Yanez Touzet, Tatiana Houhou, Zerina Rahic, Ilya Laufer, Konstantinos Margetis, Allan R Martin, Nicolas Dea, Zoher Ghogawala, Misha Kapushesky, Mark R N Kotter, Benjamin M Davies

Background: Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM research priority. Difficulties detecting DCM, and changes in DCM, cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically.

Objective: The study aims to assess the validity of MoveMed, a battery of performance outcome measures performed using a smartphone app, in the measurement of DCM.

Methods: A prospective observational study in decentralized secondary care was performed in England, United Kingdom. Validity and risk of bias were assessed using criteria from the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) manual. Each MoveMed outcome was compared with 2 patient-reported comparators, with a priori hypotheses of convergence or divergence tested against consensus thresholds. The primary outcome was the correlation coefficient between the MoveMed outcome and the patient-reported comparators. The secondary outcome was the percentage of correlations that aligned with the a priori hypotheses. The comparators used were the patient-derived modified Japanese Orthopaedic Association score and the World Health Organization Quality of Life Brief Version questionnaire. Thresholds for convergence or divergence were set at ≥0.3 for convergence, <0.3 for divergence, and >0/<0 for directionality.

Results: A total of 27 adults aged 60 (SD 11) years who live with DCM and possess an approved smartphone were included in a preliminary analysis. As expected, MoveMed tests of neuromuscular function correlated most with questionnaires of neuromuscular function (≥0.3) and least with questionnaires of quality of life (<0.3). Furthermore, directly related constructs correlated positively to each other (>0), while inversely related constructs correlated negatively (<0). Overall, 74% (67/90) and 47% (8/17) of correlations (unidimensional and multidimensional, respectively) were in accordance with hypotheses. No risk-of-bias factors from the COSMIN Risk of Bias checklist were recorded. Overall, this was equivalent to "very good" quality evidence of sufficient construct validity in DCM.

Conclusions: MoveMed outcomes and patient-reported questionnaires converge and diverge in accordance with expectations. These findings support the validity of the MoveMed tests in an adult population living with DCM. Criteria from COSMIN provide "very good" quality evidence to support this.

背景:开发新的临床措施退行性颈椎病(DCM)是AO脊柱RECODE-DCM研究的重点。检测DCM的困难以及DCM的变化导致临床诊断和治疗延迟,并由于招募目标的提高而增加了临床试验的成本。数字结果测量可以应对这些挑战,因为它们能够远程、重复和更经济地测量疾病。目的:本研究旨在评估MoveMed的有效性,MoveMed是使用智能手机应用程序进行的一系列绩效结果测量,用于测量DCM。方法:在英国英格兰进行了一项分散二级保健的前瞻性观察研究。使用COSMIN(基于共识的健康测量工具选择标准)手册中的标准评估有效性和偏倚风险。每个MoveMed结果与2个患者报告的比较物进行比较,并根据共识阈值对收敛或发散的先验假设进行检验。主要转归是MoveMed转归与患者报告的比较指标之间的相关系数。次要结果是与先验假设一致的相关性百分比。使用的比较指标是患者衍生的改良日本骨科协会评分和世界卫生组织生活质量简要版问卷。趋同或分化的阈值设置为≥0.3,趋同为0/结果:共有27名60岁(SD 11)患有DCM并拥有经批准的智能手机的成年人被纳入初步分析。正如预期的那样,MoveMed神经肌肉功能测试与神经肌肉功能问卷的相关性最大(≥0.3),与生活质量问卷的相关性最小(0),而负相关的构式呈负相关(结论:MoveMed结果与患者报告的问卷的收敛和偏离与预期一致。这些发现支持了MoveMed测试在成年DCM患者中的有效性。COSMIN的标准提供了“非常高”质量的证据来支持这一点。
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JMIR neurotechnology
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