Clinical Trial: Deep Brain Stimulation to Treat Cervical Dystonia

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

Official Title: Deep Brain Stimulation of the Globus Pallidus Interna or the Subthalamic Nucleus for Treatment of Primary Cervical Dystonia

Brief Summary:

This study will evaluate the effectiveness of deep brain stimulation (DBS) for treating primary dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are available, but not all patients get adequate relief from the abnormal movements or the pain associated with them. DBS is a surgical procedure that interrupts neuronal circuits in the globus pallidus interna (Gpi) and subthalamic nucleus (STN) - areas of the basal ganglia of the brain that do not work correctly in patients with dystonia. This results in decreased movement and therefore may lessen patients' symptoms and pain. The study will also examine the physiology of dystonia and determine whether the treatment effects of DBS in the Gpi differ significantly from DBS of the STN.

Patients 18 years of age and older with primary cervical dystonia that does not respond to medical treatment or botulinum toxin (Botox) may be eligible for this study. Candidates are screened with blood and urine tests, chest x-ray, electrocardiogram, and magnetic resonance imaging (MRI, see below) of the brain.

Each participant undergoes the following tests and procedures:

• Magnetic resonance imaging. This procedure is done after implantation of the stimulators to verify position of the electrodes. MRI uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure usually lasts about 45 to 90 minutes, during which the patient is asked to lie still for up to 15 minutes at a time.
• Transcrania
  

  Detailed Summary:

  Objective: For patients with cervical dystonia who have failed medical therapy, stereotactic deep brain stimulation (DBS) of the globus pallidus interna (Gpi) or subthalamic nucleus (STN) can provide significant symptom improvement, but it is not known which site provides maximum benefit or the physiologic mechanisms by which these improvements may occur. The study goals are to determine if DBS of Gpi or STN provides significant clinical improvement in patients with primary cervical dystonia, whether the anatomic DBS site (if either) provides optimal improvement, and to gain deeper insight into the underlying pathophysiology of this disorder.

  Study population: Adult patients with medically refractory primary cervical dystonia will make-up the study population. Patients with primary cervical dystonia suffer a wide range of symptoms including physical deformity, speech difficulties, swallowing dysfunction, visual problems, and intractable pain, which can result in an inability to care for themselves.

  Design: We propose placing DBS electrodes (using microelectrode guidance) bilaterally into either the Gpi or STN of medically refractory cervical dystonia patients. Physiological studies will be performed and compared with clinical changes to understand the mechanism of action of DBS and underlying pathophysiology of cervical dystonia.

  Outcome measures: Clinical effectiveness of DBS of the Gpi or STN will be measured by the Toronto Western Spasmodic Torticollis Scale and monitored over time to determine the effectiveness of DBS and if there is an ideal anatomic stimulation site. Electrophysiologic outcome measures will be obtained to determine the underlying pathophysiology of cervical dystonia, and the mechanism of action of DBS.

  
  Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
  

  Current Primary Outcome:
  
  

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  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: August 18, 2005
  Date Started: August 2005
  Date Completion: July 2006
  Last Updated: July 4, 2006
  Last Verified: July 2006