Clinical trials for deep brain stimulation: Current state of affairs

Irene E Harmsen; Gavin J B Elias; Michelle E Beyn; Alexandre Boutet; Aditya Pancholi; Jürgen Germann; Alireza Mansouri; Christopher S Lozano; Andres M Lozano

doi:10.1016/j.brs.2019.11.008

Clinical trials for deep brain stimulation: Current state of affairs

Brain Stimul. 2020 Mar-Apr;13(2):378-385. doi: 10.1016/j.brs.2019.11.008. Epub 2019 Nov 23.

Authors

Irene E Harmsen¹, Gavin J B Elias¹, Michelle E Beyn¹, Alexandre Boutet², Aditya Pancholi¹, Jürgen Germann¹, Alireza Mansouri³, Christopher S Lozano¹, Andres M Lozano⁴

Affiliations

¹ Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.
² Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada; Joint Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada.
³ Department of Neurosurgery, Pennsylvania State University, Hershey, PA, USA.
⁴ Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address: lozano@uhnresearch.ca.

PMID: 31786180
DOI: 10.1016/j.brs.2019.11.008

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.

Keywords: Clinical trial; Cognitive disorders; Current trends; Deep brain stimulation; Movement disorders; Psychiatric disorders.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Brain Diseases / classification
Brain Diseases / therapy*
Clinical Trials as Topic / classification
Clinical Trials as Topic / standards
Clinical Trials as Topic / statistics & numerical data*
Deep Brain Stimulation / adverse effects
Deep Brain Stimulation / methods*
Humans

Grants and funding

CIHR/Canada