Deep Brain Stimulation Surgery for Movement Disorders
Recruiting
N/AInterventional Study
Parkinson's DiseaseEssential TremorDystonia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · NIH
Who this trial is looking for
This trial is looking for adults with movement disorders like Parkinson's disease, essential tremor, or dystonia. Participants will undergo surgery to receive a device that stimulates the brain to help improve movement.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older.
I can provide informed consent.
I have a confirmed diagnosis of Parkinson's disease not well controlled by medication.
I have primary dystonia that does not respond to treatment.
I have essential tremor that is not well controlled by medications.
You may not be able to join if
I am unable or unwilling to give informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 bloc…
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.
Trial Locations
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Eligibility Criteria
* 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-di…
* 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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