Status:
RECRUITING
Sleep-specific DBS Therapy in Parkinson's Disease
Lead Sponsor:
University of Minnesota
Conditions:
Deep Brain Stimulation
Parkinson's Disease and Parkinsonism
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the...
Detailed Description
Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of idiopathic PD
- At least 21 years old
- Existing or planned 7T brain imaging
- Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
- Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away)
- Exclusion criteria:
- Other significant neurological disorder
- History of dementia
- Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- Pregnant women
- Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip
Exclusion
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05962489
Start Date
June 22 2023
End Date
August 1 2027
Last Update
February 17 2025
Active Locations (1)
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1
University Of Minnesota
Minneapolis, Minnesota, United States, 55455