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Brain pacemaker that learns: new trial aims to personalize Parkinson's treatment

NCT ID NCT03815656

Disease control Sponsor: Dennis Turner, M.D. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new approach to deep brain stimulation (DBS) for people with Parkinson's disease. Instead of the usual single electrode, researchers are placing electrodes in two brain areas and using a system that adjusts stimulation based on real-time brain signals. The goal is to see if this 'adaptive' DBS can better control symptoms like tremors and stiffness. The trial involves 46 participants who are already scheduled for DBS surgery and will be followed for up to 6 years.

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) device
What this could lead to
If successful, this could lead to more effective, personalized DBS therapy that adapts in real time to brain signals, potentially improving symptom control for Parkinson's patients.
What could go wrong
This is an early-stage study with only 46 participants, and adaptive DBS is still experimental. It may not work better than standard DBS, and there are surgical risks from electrode implantation.

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 46 people

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

Started

Jul 2019

Expected to finish

Jan 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 to 75 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.

Implanted RC+S arm Inclusion / Exclusion Criteria: Inclusion Criteria: * able to give informed consent * diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS * has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations) * has off-on improvement with levodopa of at least 30% * is available for follow-up visits for length of study Exclusion Criteria: * is not safe surgical candidate for DBS * has severe neurological injury or disease other than Parkinson's Disease * has condition requiring repeated MRI scans * has untreated, clinically significant depression * has an electrical or electromagnetic implant * had a prior thalamotomy or surgical ablation procedure * has dementia interfering with ability to comply with study requirements or give informed consent * abuses drugs or alcohol * has a history of seizures * has any metallic implants * is pregnant Speech Rater Inclusion / Exclusion Criteria: Inclusion Criteria: * able to give informed consent * has no hearing impairment (by self-report) * is a native English speaker Exclusion Criteria: * is a speech therapist or clinician in a related field * studies linguistics / logopedics

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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.

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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