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

Parkinson Disease

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Male or female \> 18 years of age
Diagnosed with idiopathic Parkinson Disease
Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months
Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;
Demonstrate ability to ambulate independently;
Be capable of providing informed consent;
If taking sleep-supporting medications, dosing must be stable for at least 30 days

Exclusion Criteria5

Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis
Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index\>=15) untreated sleep apnea, uncontrolled restless legs syndrome
Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation
Ongoing alcohol or substance abuse; Working night shifts or irregular work hours
The main concern for vulnerable subjects will be for the possibility of reduced decision-making capacity. For this we intend to exclude individuals who have a diagnosis of dementia.

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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.