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

NCT07110376 | Recruiting

• 1 other identifier: 25-323 DREAMS-PD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Average Nightly Beta Band Power

  At the end of each 2-week stimulation period (over 6 weeks total)

• Correlation Between Sleep Efficiency and Beta Band Power

  Over each night during the 6-week study period

• Correlation of Wake After Sleep Onset (WASO) with Beta Band Power

  Across 6-week study period and at the end of each 2-week stimulation phase

• Coherence Across Deep Brain Stimulation Amplitude Settings

  At the end of each 2-week stimulation period (over 6 weeks total)

• Correlation of sleep fragmentation index with Beta Band Power

  Across 6-week study period and at the end of each 2-week stimulation phase

Study Arms (1)

Evaluate the Impact of Deep Brain Stimulation Settings on Sleep

EXPERIMENTAL

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.

Other: Nighttime Deep Brain Stimulation with Varying Amplitude Settings

Interventions

Nighttime Deep Brain Stimulation with Varying Amplitude Settings OTHER

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.

Also known as: Nocturnal DBS Amplitude Modulation, DBS Sleep Modulation Protocol, 0%, 50%, 100% DBS Night Settings

Evaluate the Impact of Deep Brain Stimulation Settings on Sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Parkinson's Disease Association, Inc: collaborator
• Beacon Biosignals: collaborator
• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 441950001, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Saar Anis, MD

CONTACT

216 678-8896; ANISS2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 7, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

US (1)