Recruiting

Deep Brain Stimulation

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT01581580

Conditions

Parkinson's Disease

Essential Tremor

Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Medtronic Activa Tremor Control System

Deep Brain Stimulation

Study Details

Brief summary:

Background:

\- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery.

Objectives:

  • To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.
  • To obtain information on brain and nerve cell function during DBS surgery.

Eligibility:

\- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.

Design:

  • Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests.
  • During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier.
  • After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings.
  • Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.

Conditions

Parkinson's Disease

Essential Tremor

Dystonia

Study ID

NCT01581580

Start date

Aug 17, 2011

Status verified date

Jun 2, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: treatment arm

patients with Parkinson's Disease, dysonia, and essential tremor

Interventions

Medtronic Activa Tremor Control System

Medtronic DBS Therapy delivers electrical stimulation to an area in the brain to help treat Parkinson's Disease, dystonia, and essential tremor.

Deep Brain Stimulation

standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor

Primary outcome measure

  • physiology and efficacy of DBS surgery for movement disorders [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Sep 1, 2026

Last verified

Jun 2, 2026

Keywords

  • Parkinson's Disease
  • Deep Brain Stimulation
  • Neurophysiology
  • Movement Disorder
  • Dystonia
  • Parkinson Disease
  • Essential Tremor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-09-01.