Deep Brain Stimulation Therapy in Movement Disorders
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|ClinicalTrials.gov Identifier: NCT02119611|
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : July 16, 2018
- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).
- To provide DBS treatment to people with some movement disorders.
- Adults 18 years and older with PD, ET, or certain forms of dystonia.
- Participants will be screened with medical history and physical exam. They will have blood and urine tests and:
- MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected.
- Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity.
- Chest X-ray.
- Tests of memory, attention, concentration, thinking, and movement.
- Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol.
- Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator.
- Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Movement Disorders Deep Brain Stimulation Dystonia Essential Tremor||Other: Deep Brain Stimulation Management||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation Therapy in Movement Disorders|
|Study Start Date :||April 16, 2014|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||August 31, 2018|
- Other: Deep Brain Stimulation Management
- To train NINDS Medical Neurology Branch and Parkinson Clinic fellows in the method of DBS surgery and subsequent stimulator management in the treatment of medically refractory PD, dystonia, ET. [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119611
|Contact: Irene H Dustin, C.R.N.P.||(301) firstname.lastname@example.org|
|Contact: Debra J Ehrlich, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Debra J Ehrlich, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|