Can tuning brain stimulation at night help Parkinson's patients sleep better?

NCT ID NCT07110376

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study is testing whether changing the strength of deep brain stimulation (DBS) during sleep can help people with Parkinson's disease sleep better. Ten participants will try three different nighttime DBS settings (off, half strength, and full strength) for two weeks each. The goal is to see which setting improves sleep efficiency the most, using a headband to track sleep and brain recordings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Deep brain stimulation (DBS) with varying nighttime amplitude settings (0%, 50%, 100% of clinical settings)
What this could lead to: If successful, this could point toward a way to adjust DBS during sleep to improve rest and quality of life for people with Parkinson's.
What could go wrong: This is a very small, early exploratory study with only 10 participants, so results may not apply to everyone. It focuses on sleep, not on changing the course of Parkinson's itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Can tuning brain stimulation at night help Parkinson's patients sleep better?

What the study statuses mean