RecruitingNot ApplicableNCT05962489

Sleep-specific DBS Therapy in Parkinson's Disease

Sponsor

University of Minnesota

Enrollment

64 participants

Start Date

Jun 22, 2023

Study Type

INTERVENTIONAL

Conditions

Dystonia Deep Brain Stimulation Parkinson's Disease and Parkinsonism

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 U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.

Eligibility

Min Age: 21 Years

Inclusion Criteria5

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 Criteria5

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

Interventions

OTHERClinically optimized deep brain stimulation

Participants will have DBS implanted as standard-of-care. We will be examining the effects of their regular clinical stimulation settings versus no stimulation.