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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00132340 |
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:
Neurologic evaluations with the TWSTRS scale are repeated at 1, 2, 3, 6 and 12 months after surgery, and the stimulators are adjusted as needed. Some of the evaluations are videotaped.
Condition | Intervention | Phase |
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Cervical Dystonia |
Device: Electrodes |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Deep Brain Stimulation of the Globus Pallidus Interna or the Subthalamic Nucleus for Treatment of Primary Cervical Dystonia |
Estimated Enrollment: | 40 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | July 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible for entry into the study, candidates must meet all the following criteria:
EXCLUSION CRITERIA
Candidates will be excluded if:
Study ID Numbers: | 050222, 05-N-0222 |
Study First Received: | August 18, 2005 |
Last Updated: | July 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00132340 |
Health Authority: | United States: Federal Government |
Spasmodic Torticollis Treatment Physiology |
Surgery Cervical Dystonia Spasmodic Torticollis |
Dystonic Disorders Signs and Symptoms Torticollis Movement Disorders |
Central Nervous System Diseases Neurologic Manifestations Dystonia Dyskinesias |
Nervous System Diseases |