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 : November 23, 2020
- 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||Device: Deep Brain Stimulation Management||Not Applicable|
|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|
|Actual Study Start Date :||September 18, 2014|
|Estimated Primary Completion Date :||December 1, 2030|
|Estimated Study Completion Date :||December 1, 2030|
Device: Deep Brain Stimulation Management
The DBS surgery will be performed according to standard of care in the centers of referral. If performed at the NIH, this will be done under protocol 11-N-0211 or other protocols permitting DBS surgery depending on future availability.
- To provide DBS therapy and follow-up management [ Time Frame: two years ]a. Severity of PD motor symptoms (measured by the UPDRS III scale)b. Changes in dystonia severity (measured by the Burke-Fahn-Marsden (BFM) dystonia rating scale (Burke et al., 1985)c. Changes in tremor severity (measured by the Tremor Rating Scale (TRS))d. Levels of effective drug therapy for PD patients using the Levodopa Equivalent Drug Dosing (LEDD)e. Changes in behavior, performance of activities of daily living and complications of therapy as measured by the UPDRS I, II, and IV scales2. To evaluate effects of DBS before and 1 year after surgery on quality of life:a. For PD patients (measured by UPDRS part II and other scales such as the PDQ-39)b. For the Dystonia and ET patients (measured by the SF-12 scale)3. To evaluate radiographic correlation of DBS electrode position and clinical changes4. To evaluate neurophysiological mechanisms of DBS and relevant basal gangliaphysiology
- To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology [ Time Frame: ongoing ]To potentially enroll subjects in other NIH studies
- Data collection [ Time Frame: ongoing ]All the data collected will be an outcome of standard of care and all analyses will be retrospective
- To access other clinical outcome measures related to response to therapy [ Time Frame: 2 years ]Data collection
- To correlate radiographic data related to DBS electrode position with clinical changes [ Time Frame: 2 years ]Data collection
- To collect physiology data correlated with motor and cognitive function in these [ Time Frame: 2 years ]Data collection
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) email@example.com|
|Contact: Debra J Ehrlich, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Debra J Ehrlich, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|