This study is currently recruiting participants.
Number
11-N-0211
Sponsoring Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 99 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Parkinson's Disease; Deep Brain Stimulation; Neurophysiology; Movement Disorder; Dystonia
Recruitment Keyword(s)
Parkinson Disease; Essential Tremor; Movement Disorder
Condition(s)
Parkinson's Disease; Essential Tremor; Dystonia
Investigational Drug(s)
None
Investigational Device(s)
Medtronic Activa Tremor Control System Subdural Surface Electrodes
Intervention(s)
Device: Medtronic Activa Tremor Control System Procedure/Surgery: Deep Brain Stimulation
Supporting Site
National Institute of Neurological Disorders and Stroke
- 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.
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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.
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.
Principal Investigator
Referral Contact
For more information: