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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Saar Anis, MD
ANISS2@ccf.org
216 678-8896
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Evaluate the Impact of Deep Brain Stimulation Settings on Sleep
Participants with Parkinson's disease implanted with a Medtronic Percept™ deep brain stimulation (DBS) system will undergo a 6-week in-home monitoring protocol. Each participant will be exposed to three different nighttime-only DBS stimulation settings in a randomized 2-week crossover design: (1) no stimulation (0% amplitude), (2) reduced stimulation (50% amplitude), and (3) optimal clinical stimulation. Sleep metrics will be collected nightly using the Dreem Headband wearable electroencephalogram (EEG) device. One night of polysomnography will also be conducted to validate the wearable. Subcortical local field potentials (LFPs) from the subthalamic nucleus will be recorded to assess band power and coherence during different stimulation settings and sleep stages. The study aims to evaluate the effect of DBS settings on sleep efficiency, spectral features of neural activity, and their correlation.
Sponsors
Leads: The Cleveland Clinic
Collaborators: Beacon Biosignals, American Parkinson's Disease Association, Inc

This content was sourced from clinicaltrials.gov

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