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Brain pacemaker surgery tested for Parkinson's and tremor

NCT ID NCT01581580

Disease control Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 02, 2026 · Updated 12 times

Summary

This study is testing deep brain stimulation (DBS) surgery for people with Parkinson's disease, essential tremor, or dystonia that doesn't improve enough with medication. DBS uses a device like a pacemaker to send electrical pulses to specific brain areas that control movement. Researchers will track changes in movement, memory, and quality of life over several months after surgery.

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 and surgical procedure
What this could lead to
If successful, this could confirm DBS as a reliable way to control severe movement symptoms and improve daily function for people with Parkinson's, tremor, or dystonia.
What could go wrong
This is an ongoing study with no phase designation, so results are not yet confirmed. DBS surgery carries risks like infection, bleeding, or device malfunction, and benefits vary by person.

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 200 people

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

Started

Aug 2011

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 99 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: To be eligible for entry into the study, candidates must meet all the following criteria: Be 18 years of age or older. Able to provide informed consent. Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy: * idiopathic PD not adequately controlled with medication or * primary dystonia that is medically refractory, or * ET that is not adequately controlled by medications or constitutes a significant functional disability. EXCLUSION CRITERIA: Candidates will be excluded if they: Are unable or unwilling to give informed consent to the research procedures.

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Conditions

The condition(s) this trial relates to.

Dystonia dystonic disorder essential tremor movement disorder Parkinson disease

As listed by the trial registrant

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

Dystonia Essential tremor Parkinson's 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

    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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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