Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT07110376

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nighttime Deep Brain Stimulation with Varying Amplitude Settings

Study Details

Brief summary:

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

Conditions

Parkinson Disease

Study ID

NCT07110376

Start date

Nov 22, 2025

Status verified date

Oct, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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 subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.

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 and Locations

Central contacts

Saar Anis, MD

216 678-8896ANISS2@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 441950001

Contacts

Project Manager

216-372-2867beukemm@ccf.org

Saar Anis, MD

216 678-8896ANISS2@ccf.org

Principal Investigator:

James Liao, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 28, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-28.