Protocol Details
Deep Brain Stimulation Surgery for Movement Disorders
This study is currently recruiting participants.
Summary
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 |
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.
Eligibility
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.
Citations:
de Lau LM, Breteler MM. Epidemiology of Parkinson s disease. Lancet Neurol. 2006 Jun;5(6):525-35.
DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5.
Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71.
Contacts:
Clinical Trials Number:
NCT01581580