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Clinical Trial NCT07110376 (DREAMS-PD) for Parkinson Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease (DREAMS-PD) 10 Randomized Crossover Design

Recruiting
Clinical Trial NCT07110376 (DREAMS-PD) is an interventional study for Parkinson Disease that is recruiting. It started on 22 November 2025 with plans to enroll 10 participants. Led by The Cleveland Clinic, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 15 December 2025.
Brief Summary
This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.
Detailed Description
Deep brain stimulation (DBS) stands as an established and robust treatment for various motor symptoms in patients with Parkinson's disease (PWP). While it has shown promise in ameliorating non-motor symptoms, the mechanisms underlying these improvements remain poorly understood. A significant forthcoming shift in the DBS landscape is the transition towards closed-loop or "adaptive DBS" (aDBS). This approach relies on...Show More
Official Title

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

Conditions
Parkinson Disease
Other Study IDs
  • DREAMS-PD
  • 25-323 DREAMS-PD
NCT ID Number
NCT07110376
Start Date (Actual)
2025-11-22
Last Update Posted
2025-12-15
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Supportive Care
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEvaluate 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 metric...Show More
Nighttime 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 subthal...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
To demonstrate differences in sleep efficiency (SE) among different stimulation settings.
Sleep efficiency will be calculated as: (total sleep time ÷ total time in bed) × 100, using nightly data collected via the Dreem Headband. The mean SE for each 2-week stimulation setting (0%, 50%, 100% amplitude) will be compared within subjects using crossover analysis.
At the end of each 2-week stimulation period (over 6 weeks total)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Average Nightly Beta Band Power
Average beta band power will be derived from subthalamic nucleus local field potentials recorded via the Medtronic Percept™ system.
At the end of each 2-week stimulation period (over 6 weeks total)
Correlation Between Sleep Efficiency and Beta Band Power
The correlation between sleep efficiency (measured by Dreem Headband) and beta band power (recorded from DBS electrodes) will be evaluated. Analyses will include full-night averages and specific sleep stages (N1/N2, N3).
Over each night during the 6-week study period
Correlation of Wake After Sleep Onset (WASO) with Beta Band Power
Wake after sleep onset (WASO) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Across 6-week study period and at the end of each 2-week stimulation phase
Coherence Across Deep Brain Stimulation Amplitude Settings
Coherence between left and right subthalamic nucleus (STN) will be calculated. Comparisons will be made across the three stimulation settings
At the end of each 2-week stimulation period (over 6 weeks total)
Correlation of sleep fragmentation index with Beta Band Power
Sleep fragmentation index will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Across 6-week study period and at the end of each 2-week stimulation phase
Correlation of Pittsburgh Sleep Quality Index (PSQI) with Beta Band Power
Pittsburgh Sleep Quality Index (PSQI) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Across 6-week study period and at the end of each 2-week stimulation phase
Correlation of and Epworth Sleepiness Scale (ESS) with Beta Band Power
Epworth Sleepiness Scale (ESS) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Across 6-week study period and at the end of each 2-week stimulation phase
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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.

The Cleveland Clinic logoThe Cleveland Clinic
  • American Parkinson's Disease Association, Inc logoAmerican Parkinson's Disease Association, Inc
  • Beacon Biosignals logoBeacon Biosignals
Study Responsible Party
James Liao, Principal Investigator, Staff Physician, The Cleveland Clinic
Study Central Contact
Contact: Saar Anis, MD, 216 678-8896, [email protected]
1 Study Locations in 1 Countries

Ohio

Cleveland Clinic, Cleveland, Ohio, 441950001, United States
Project Manager, Contact, 216-372-2867, [email protected]
Saar Anis, MD, Contact, 216 678-8896, [email protected]
James Liao, MD, Principal Investigator
Recruiting