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Deep Brain Stimulation for Sleep in Parkinson's Disease

This study is looking at how different settings of Deep Brain Stimulation (DBS) affect sleep in people with Parkinson's disease. Participants will have their existing Medtronic PerceptTM PC DBS system adjusted to three different settings during the night: off, 50% of their usual setting, and 100% of their usual setting. Each setting will be used for two weeks. The main goal is to see if there are differences in how well people sleep (sleep efficiency) with these different settings. You can join if you are over 18, have Parkinson's disease, and have had a bilateral Medtronic PerceptTM PC DBS system targeting the subthalamic nucleus (STN) for at least three months with optimized settings. The study plans to enroll 10 participants.

Study design
This is an interventional study with a randomized crossover design, meaning participants will try all three stimulation settings in a random order. It plans to enroll 10 participants.
What's involved
Participants will undergo three different nighttime-only Deep Brain Stimulation settings, each for a period of two weeks, for a total of six weeks.
Compensation
Not stated in the trial record.
Follow-up
Sleep efficiency will be measured at the end of each 2-week stimulation period, over a total of 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07110376

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

Recruiting
NAAges 18+InterventionalSupportive care
The Cleveland Clinic
~10 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Nighttime Deep Brain Stimulation with Varying Amplitude Settings

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To demonstrate differences in sleep efficiency (SE) among different stimulation settings.
Measured over At the end of each 2-week stimulation period (over 6 weeks total)

Conditions

Parkinson Disease

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Parkinson Disease

NCT07110376

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Saar Anis, MD
[email protected]
216 678-8896
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

    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.