Clinical Trial: Deep Brain Stimulation for 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 Generalized Primary Dystonia

Brief Summary:

This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating primary generalized 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 Gpi and STN, areas of the basal ganglia of the brain that do not work correctly in patients with dystonia. The surgery results in decreased movement and therefore may lessen patients' symptoms and pain.

Patients 7 years of age and older with generalized dystonia that does not respond to medical treatment may be eligible for this study. Candidates are screened with blood and urine tests, chest x-ray, and an electrocardiogram in patients 35 years of age or more.

Participants undergo the following tests and procedures:

  • Magnetic resonance imaging. 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.
  • Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the patient may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause

    Detailed Summary:

    OBJECTIVE:

    For dystonic patients 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 generalized 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 and pediatric patients with medically refractory primary generalized dystonia will make-up the study population. Patients with primary generalized 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. Moreover, pediatric primary generalized dystonia patients will often have abnormal skeletal development (scoliosis) resulting from the abnormal forces placed on the skeleton by dystonic muscle contractions.

    DESIGN:

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

    OUTCOME MEASURES:

    Clinical effectiveness of DBS of the
    Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

    Current Primary Outcome: Clinical effectiveness of DBS of the Gpi or STN will be measured by the Burke-Fahn-Marsden Scale (BFM) and monitored over time to determine the effectiveness DBS and if there is an ideal anatomic stimulation site.@@@@@@@@@

    Original Primary Outcome:

    Current Secondary Outcome: Determine the underlying pathophysiology of dystonia, and the mechanism of action of DBS.

    Original Secondary Outcome:

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

    Dates:
    Date Received: March 11, 2005
    Date Started: March 2005
    Date Completion: July 2006
    Last Updated: July 4, 2006
    Last Verified: July 2006