Deep Brain Stimulation in Patients With Dystonia (STN DBS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00773604
First received: October 7, 2008
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Dystonia
Device: Medtronic implantable deep brain stimulation (DBS) system
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) in Patients With Dystonia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Medtronic implantable deep brain stimulation (DBS) system
    surgical placement of deep brain stimulation system for treatment of 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 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. Changes in cognitive function will be assessed with neuropsychological testing. Stimulation parameters will be documented, and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects. Patient weight will be recorded at study visits. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.

  Eligibility

Ages Eligible for Study:   7 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773604

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
San Francisco Veterans Administration Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jill Ostrem, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00773604     History of Changes
Other Study ID Numbers: Private donor
Study First Received: October 7, 2008
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
blepharospasm
Deep brain Stimulation
cervical dystonia
cranial dystonia
generalized dystonia
subthalamic nucleus
DBS

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 25, 2014