Deep Brain Stimulation in Treating Patients With Dystonia
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|ClinicalTrials.gov Identifier: NCT00004421|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.
PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.
|Condition or disease||Intervention/treatment||Phase|
|Dystonia||Device: implanted pulse generator||Phase 2 Phase 3|
PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months.
Patients are followed every 3 months as long as the brain stimulation system remains in place.
Completion date provided represents the completion date of the grant per OOPD records
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Official Title:||Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia|
|Study Start Date :||September 1997|
|Study Completion Date :||September 2000|
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): NCT00004421
|United States, New York|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|Study Chair:||Mitchell Francis Brin||Icahn School of Medicine at Mount Sinai|