Status:
COMPLETED
Deep Brain Stimulation in Patients With Dystonia
Lead Sponsor:
University of California, San Francisco
Conditions:
Dystonia
Eligibility:
All Genders
7-80 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.
Detailed Description
Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two gr...
Eligibility Criteria
Inclusion
- Refractory primary dystonia diagnosed by a movement disorders neurologist
- Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
- Age 7-80 years (UCSF patients) and 18-80 (VA patients)
Exclusion
- Patients considered at high risk for elective neurosurgery because of co-morbid conditions
- Brain MRI showing extensive brain atrophy or small vessel ischemic disease
- Pregnancy
- Inability to tolerate awake microelectrode-guided neurosurgery
- Inability to follow up with post-operative study visits
- Inability to speak or read English
- Patients with a score of 4.5 or lower on the BFMDRS movement scale
- Patients with Secondary dystonia
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00773604
Start Date
June 1 2008
End Date
February 1 2015
Last Update
February 19 2019
Active Locations (2)
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1
San Francisco Veterans Administration Medical Center
San Francisco, California, United States, 94121
2
University of California, San Francisco
San Francisco, California, United States, 94143