Deep Brain Stimulation Therapy in Movement Disorders (NCT02119611) | Clinical Trial Compass
RecruitingNot Applicable
Deep Brain Stimulation Therapy in Movement Disorders
United States300 participantsStarted 2014-04-02
Plain-language summary
Background:
\- 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).
Objective:
\- To provide DBS treatment to people with some movement disorders.
Eligibility:
\- Adults 18 years and older with PD, ET, or certain forms of dystonia.
Design:
* 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic.
✓. The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic.
✓. The diagnosis of ET will be confirmed on clinical examination in the NIH Movement Disorders Clinic (the diagnosis of ET will be based on bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Additional or isolated tremor in head may be present but there should be the absence of abnormal posturing).
✓. good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR
✓. intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing spells) OR
✓. intractable symptoms of ET or dystonia impacting at least 2 activities of daily living.
Exclusion criteria
✕. History of stroke, exposure to toxins, neuroleptics, or encephalitis
What they're measuring
1
To provide DBS therapy and follow-up management
Timeframe: two years
2
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
Timeframe: ongoing
3
Data collection
Timeframe: ongoing
Trial details
NCT IDNCT02119611
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)