Publication Rates and Characteristics of Clinical Trials in Deep Brain and Responsive Neurostimulation.

IF 1.9 4区医学 Q3 NEUROIMAGING Stereotactic and Functional Neurosurgery Pub Date : 2023-01-01 Epub Date: 2023-08-08 DOI:10.1159/000531161

Melissa M J Chua, Aaron E L Warren, G Rees Cosgrove, John D Rolston

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引用次数: 1

Abstract

Introduction: Prompt dissemination of clinical trial results is essential for ensuring the safety and efficacy of intracranial neurostimulation treatments, including deep brain stimulation (DBS) and responsive neurostimulation (RNS). However, the frequency and completeness of results publication, and reasons for reporting delays, are unknown. Moreover, the patient populations, targeted anatomical locations, and stimulation parameters should be clearly reported for both reproducibility and to identify lacunae in trial design. Here, we examine DBS and RNS trials from 1997 to 2022, chart their characteristics, and examine rates and predictors of results reporting.

Methods: Trials were identified using ClinicalTrials.gov. Associated publications were identified using ClinicalTrials.gov and PubMed.gov. Pearson's χ2 tests were used to assess differences in trial characteristics between published and unpublished trials.

Results: Across 449 trials, representing a cumulative cohort of 42,769 patient interventions, there were 37 therapeutic indications and 44 stimulation targets. The most common indication and target were Parkinson's disease (40.55%) and the subthalamic nucleus (35.88%), respectively. Only 0.89% of trials were in pediatric patients (11.58% were mixed pediatric and adult). Explored targets represented 75% of potential basal ganglia targets but only 29% of potential thalamic targets. Allowing a 1-year grace period after trial completion, 34/169 (20.12%) had results reported on ClinicalTrials.gov, and 107/169 (63.31%) were published. ∼80% of published trials included details about stimulation parameters used. Published and unpublished trials did not significantly differ by trial characteristics.

Conclusion: We highlight key knowledge and performance gaps in DBS and RNS trial research. Over one-third of trials remain unpublished >1 year after completion; pediatric trials are scarce; most of the thalamus remains unexplored; about one-in-five trials fail to report stimulation parameters; and movement disorders comprise the most studied indications.

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脑深部和反应性神经刺激临床试验的发表率和特点。

引言：及时传播临床试验结果对于确保颅内神经刺激治疗的安全性和有效性至关重要，包括脑深部刺激（DBS）和反应性神经刺激（RNS）。然而，结果公布的频率和完整性以及报告延迟的原因尚不清楚。此外，在试验设计中，应清楚地报告患者群体、靶向解剖位置和刺激参数的再现性和识别腔隙。在这里，我们检查了1997年至2022年的DBS和RNS试验，绘制了它们的特征，并检查了结果报告的比率和预测因素。方法：使用ClinicalTrials.gov确定试验。使用ClinicalTrials.gov和PubMed.gov确定相关出版物。使用Pearsonχ2检验评估已发表和未发表试验之间的试验特征差异。结果：在449项试验中，代表42769名患者干预的累积队列，有37个治疗适应症和44个刺激靶点。最常见的适应症和靶点分别是帕金森氏症（40.55%）和丘脑底核（35.88%）。只有0.89%的试验是在儿科患者中进行的（11.58%是儿童和成人的混合试验）。爆炸靶点占潜在基底神经节靶点的75%，但仅占潜在丘脑靶点的29%。试验完成后允许1年的宽限期，34/169（20.12%）在ClinicalTrials.gov上报告了结果，107/169（63.31%）发表了结果80%的已发表试验包括所用刺激参数的详细信息。已发表和未发表的试验在试验特征方面没有显著差异。结论：我们强调了DBS和RNS试验研究中的关键知识和性能差距。超过三分之一的试验仍未发表>；竣工后1年；儿科试验很少；丘脑的大部分仍未被探索；大约五分之一的试验没有报告刺激参数；运动障碍包括研究最多的适应症。

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来源期刊

Stereotactic and Functional Neurosurgery 医学-神经成像

CiteScore

3.80

自引率

0.00%

发文量

审稿时长

3 months

期刊介绍： ''Stereotactic and Functional Neurosurgery'' provides a single source for the reader to keep abreast of developments in the most rapidly advancing subspecialty within neurosurgery. Technological advances in computer-assisted surgery, robotics, imaging and neurophysiology are being applied to clinical problems with ever-increasing rapidity in stereotaxis more than any other field, providing opportunities for new approaches to surgical and radiotherapeutic management of diseases of the brain, spinal cord, and spine. Issues feature advances in the use of deep-brain stimulation, imaging-guided techniques in stereotactic biopsy and craniotomy, stereotactic radiosurgery, and stereotactically implanted and guided radiotherapeutics and biologicals in the treatment of functional and movement disorders, brain tumors, and other diseases of the brain. Background information from basic science laboratories related to such clinical advances provides the reader with an overall perspective of this field. Proceedings and abstracts from many of the key international meetings furnish an overview of this specialty available nowhere else. ''Stereotactic and Functional Neurosurgery'' meets the information needs of both investigators and clinicians in this rapidly advancing field.