MedPath

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

Not Applicable
Not yet recruiting
Conditions
Parkinson's disease
Neurological - Parkinson's disease
Registration Number
ACTRN12624000687594
Lead Sponsor
Deep Brain Stimulation Technologies
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
300
Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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