NCT05962489 Sleep-specific DBS Therapy in Parkinson's Disease

Trial Parameters

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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 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 Criteria

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

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