Deep Brain Stimulation in Patients With Dystonia

Completed · Not applicable

Conditions studied: Dystonia

In brief

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.

Key facts

Study ID

NCT00773604

Run by

University of California, San Francisco

People needed

9

Starts

2008-06-01

Expected to finish

2015-02-01

Last updated by the study team

2019-02-19

Who can join

Age: 7 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• San Francisco Veterans Administration Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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