NCT01581580

Deep Brain Stimulation Surgery for Movement Disorders

Recruiting now NA Last updated 8 April 2026

What this trial tests

NA trial testing Medtronic Activa Tremor Control System in Parkinson's Disease in 200 participants. Currently enrolling.

Timeline

17 August 2011

Primary endpoint
1 December 2029

1 December 2029

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	17 August 2011
Primary completion	1 December 2029
Estimated completion	1 December 2029
Sites	1 location across United States

Drugs / interventions tested

• Medtronic Activa Tremor Control System
• Deep Brain Stimulation

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →
• Essential Tremor — all drugs for Essential Tremor →
• Dystonia — all drugs for Dystonia →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 99, any sex, with Parkinson's Disease or Essential Tremor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.