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Brain pacemaker study aims to unlock sleep secrets in Parkinson's

NCT ID NCT05962489

Knowledge-focused Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how deep brain stimulation (DBS) — a device already used to control movement in Parkinson's disease — affects sleep. Researchers will monitor brain activity and sleep quality in 64 adults with Parkinson's who have or will get DBS implants. The goal is to understand which brain circuits are involved in sleep problems and to guide future treatments.

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
What this could lead to
If successful, this could point toward targeted therapies to improve sleep in people with Parkinson's disease.
What could go wrong
This is an early-stage observational study with only 64 participants, so results may not apply broadly. It focuses on understanding brain activity, not testing a new treatment.

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 64 people

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

Started

Jun 2023

Expected to finish

Aug 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

21 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: * Diagnosis of idiopathic PD * At least 21 years old * Existing or planned 7T brain imaging * Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care * Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away) Exclusion criteria: * Other significant neurological disorder * History of dementia * Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study * Pregnant women * Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

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Conditions

The condition(s) this trial relates to.

Dystonia dystonic disorder Parkinson disease parkinsonian disorder

As listed by the trial registrant

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

Deep brain stimulation Dystonia Parkinson's disease and parkinsonism

How to take part

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

  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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