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Clinical trials for deep brain stimulation: Current state of affairs.

Abstract：

BACKGROUND:Deep brain stimulation (DBS) is a surgical neuromodulation procedure with a historically wide range of possible therapeutic indications, including movement disorders, neuropsychiatric conditions, and cognitive disorders. Ongoing research in this field is critical to gain further insights into the mechanisms of DBS, to discover novel brain targets for new and existing indications, and to refine targeting and post-operative programming techniques for the optimization of therapeutic outcomes. OBJECTIVE:To update on the state of DBS-related clinical human research by cataloging and summarizing clinical trials that have been completed or are currently ongoing in this field worldwide. METHODS:A search was conducted for clinical trials pertaining to DBS, currently listed on the ClinicalTrials.gov database. Trials were analyzed to generate a detailed overview of ongoing DBS-related research. Specifically, trials were categorized by trial start date, study completion status, clinical phase, projected subject enrollment, disorder, brain target, country of origin, device manufacturer, funding source, and study topic. RESULTS:In total, 384 relevant clinical trials were identified. The trials spanned 28 different disorders across 26 distinct brain targets, with almost 40% of trials being for conditions other than movement disorders. The majority of DBS trials have been US-based (41.9% of studies) but many countries are becoming increasingly active. The ratio of investigator-sponsored to industry-sponsored trials was 3:1. Emphasizing the need to better understand the mechanism of action of DBS, one-third of the studies predominantly focus on imaging or electrophysiological changes associated with DBS. CONCLUSIONS:This overview of current DBS-related clinical trials provides insight into the status of DBS research and what we can anticipate in the future concerning new brain targets, indications, techniques, and developing a better understanding of the mechanisms of action of DBS.

journal_name

Brain Stimul

journal_title

Brain stimulation

authors

Harmsen IE,Elias GJB,Beyn ME,Boutet A,Pancholi A,Germann J,Mansouri A,Lozano CS,Lozano AM

doi

10.1016/j.brs.2019.11.008

subject

Has Abstract

pub_date

2020-01-01 00:00:00

pages

378-385

issue

eissn

1935-861X

issn

1876-4754

pii

S1935-861X(19)30466-8

journal_volume

pub_type

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Clinical trials for deep brain stimulation: Current state of affairs.