A multi-center study to investigate the utility of biosignals recorded during deep brain stimulation in adults.

Deep Brain Stimulation Technologies0 sites300 target enrollmentMay 30, 2024

Overview

No summary available.

Registry

who.int

Start Date

May 30, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Deep Brain Stimulation Technologies

•Participants are eligible to be included in the study only if all the following criteria apply:
•Participants aged 18 years or older at the time of recruitment into the study.
•Participants who have planned to have deep brain stimulation surgery for the first time or participants who have previously been implanted with deep brain stimulation systems who are planning to undergo revision surgery to either add a DBS system, remove, replace, or reposition any component of the DBS system.
•Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form
•In addition to the above inclusion criteria, participants are eligible for the sub\-study if the following criteria apply:
•Participants who have been diagnosed with Parkinson’s disease

•Participants are ineligible to be included in the study if one or more of the following criteria apply:
•Participants with dementia, or a significant psychiatric, behavioural or any other issue which, in the opinion of the investigators, might significantly compromise their ability to understand or complete the study protocol.
•In addition to the above exclusion criteria, participants will be excluded from the sub\-study if the following criteria apply:
•Any complications from the DBS surgery (such as a malpositioned electrode) or any other issue which, in the opinion of the investigators, might compromise the participant’s ability to complete the protocol.