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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07110376
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Nov 22, 2025
Status verified
Oct 2025
Primary completion
Jul 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

To demonstrate differences in sleep efficiency (SE) among different stimulation settings. [ Time Frame: At the end of each 2-week stimulation period (over 6 weeks total) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio441950001
Project Manager
[email protected]
216-372-2867
Saar Anis, MD
[email protected]
216 678-8896
James Liao, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Cleveland Clinic· Cleveland, OH

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