Clinical Trial: Deep Brain Stimulation in Patients With Dystonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) in Patients With Dystonia

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 Summary: 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 groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). Deep brain stimulation (DBS) has been shown to be an effective treatment in patients with medically refractory dystonia and is currently approved for both the GPi and STN targets under a humanitarian device exemption (HDE) for use in segmental and generalized primary dystonia as well as focal cervical dystonia. GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study are to 1) evaluate the safety and efficacy of STN DBS for dystonia; 2) determine the time course of STN potential efficacy and optimal stimulation parameters; and 3) determine the frequency and severity of stimulation-induced motor adverse effects in previously non-dystonic body regions. Twenty-five patients will be screened, consented, and enrolled in this study. All patients will undergo bilateral STN DBS for dystonia. Participants will be evaluated pre- and postoperatively with standard dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), the Jankovic Rating Scale (JRS), and Clinical Global Improvement (CGI) rating scale. C
Sponsor: University of California, San Francisco

Current Primary Outcome: The primary outcome measure is the change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score from baseline to 12 months. [ Time Frame: 36 months ]

Original Primary Outcome: The primary outcome measure is the change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score from baseline to 6 months. [ Time Frame: 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: October 7, 2008
Date Started: June 2008
Date Completion:
Last Updated: August 5, 2015
Last Verified: August 2015