RecruitingNot ApplicableNCT07110376

Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease

Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study


Sponsor

The Cleveland Clinic

Enrollment

10 participants

Start Date

Nov 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how different deep brain stimulation (DBS) settings affect brain activity and sleep in people with Parkinson's disease who already have a DBS device implanted. Researchers will record brain signals overnight to understand how stimulation patterns relate to sleep quality. **You may be eligible if...** - You are 18 years or older with a diagnosis of Parkinson's disease - You have a Medtronic Percept PC DBS device implanted in both sides of the brain (targeting the subthalamic nucleus) - Your DBS settings have been stable for at least 3 months - You report sleep disturbances related to Parkinson's (score of 1+ on a standard rating scale) - You can walk independently - If taking sleep medications, the dose has been stable for at least 30 days **You may NOT be eligible if...** - You have another neurological condition (such as stroke or multiple sclerosis) - You have untreated moderate-to-severe sleep apnea or other active sleep disorder - You have dementia - You have a history of significant alcohol or substance use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNighttime Deep Brain Stimulation with Varying Amplitude Settings

Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT07110376


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