Deep Brain Stimulation to Treat Cervical Dystonia
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|ClinicalTrials.gov Identifier: NCT00132340|
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : July 6, 2006
|First Submitted Date ICMJE||August 18, 2005|
|First Posted Date ICMJE||August 19, 2005|
|Last Update Posted Date||July 6, 2006|
|Study Start Date ICMJE||August 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00132340 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Deep Brain Stimulation to Treat Cervical Dystonia|
|Official Title ICMJE||Deep Brain Stimulation of the Globus Pallidus Interna or the Subthalamic Nucleus for Treatment of Primary Cervical Dystonia|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Cervical Dystonia|
|Intervention ICMJE||Device: Electrodes|
|Study Arms ICMJE||Not Provided|
|Publications *||Jankovic J, Leder S, Warner D, Schwartz K. Cervical dystonia: clinical findings and associated movement disorders. Neurology. 1991 Jul;41(7):1088-91.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||July 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for entry into the study, candidates must meet all the following criteria:
Candidates will be excluded if:
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00132340|
|Other Study ID Numbers ICMJE||050222
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP