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Brain stimulation that adapts to sleep stages could restore rest in Parkinson's

NCT ID NCT04620551

Disease control Sponsor: University of Nebraska Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests whether a smart deep brain stimulation (DBS) device can improve sleep in people with Parkinson's disease. The device records brain signals to identify sleep stages and then delivers stimulation only during certain phases to promote deeper, restorative sleep. Researchers will compare sleep patterns with and without this adaptive stimulation in 20 Parkinson's patients who already have DBS implants. The goal is to see if this approach can ease sleep problems that often accompany Parkinson's.

What this could mean

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

Active substance
Adaptive deep brain stimulation (DBS) using the Medtronic RC+S Summit System
What this could lead to
If successful, this could lead to a new way to improve sleep quality in Parkinson's patients using personalized brain stimulation, potentially reducing reliance on sedative drugs.
What could go wrong
This is a small early-stage study (20 participants) focused on feasibility and biomarkers, so results may not apply broadly. Risks include surgical complications from DBS and the possibility that adaptive stimulation may not consistently improve sleep.

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

20 people

The number who actually took part.

Started

Oct 2020

Finished

Jun 2026

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

21 to 80 years

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: * Ability to provide informed consent for this study * Diagnosis of Idiopathic Parkinson's disease with motor symptoms that have been present for a minimum of 4 years * Motor symptoms are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS * UPDRS-III score off medication between 20 and 80, and an improvement in UPDRS-III score on medications of at least 30%, or patients with tremor-dominant PD (score \>/= 2 on UPDRS-III tremor sub-score)-or tremor in addition to other motor symptoms-that is treatment-resistant and results in significant functional disability * Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms * Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery * Absence of significant cognitive deficits or significant depression (BDI-II score \> 20) on formal Neuropsychological Testing * Age 21 - 80 years Exclusion Criteria: * Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia * Pregnancy * Significant untreated depression (BDI-II score \> 20) * Personality or mood disorder symptoms that Study Personnel believe will interfere with study requirements * Patients requiring ongoing treatment with ECT, rTMS, or diathermy * Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease) or ferromagnetic metallic implant * Prior intracranial surgery * History of, or active, drug or alcohol abuse * Meets criteria for PD with Mild Cognitive Impairment (PD-MCI), as defined by Performance \> 2 standard deviations below appropriate norms on tests from 2 or more of the following cognitive domains: Attention, Executive Function, Language, Memory, and Visuospatial Ability * Patients with Restless Leg Syndrome

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Conditions

The condition(s) this trial relates to.

Parkinson disease Sleep Deprivation

As listed by the trial registrant

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

Parkinson disease Sleep fragmentation

Contacts and locations

Locations

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.