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Sponsors and Collaborators: |
University of Calgary Canadian Institutes of Health Research (CIHR) Calgary Health Region Medtronic |
Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00132990 |
The purposes of this study are:
Condition | Intervention |
Cervical Dystonia |
Device: Deep brain stimulation |
Genetics Home Reference related topics: | early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia |
MedlinePlus related topics: | Dystonia |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia |
Estimated Enrollment: | 10 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | September 2005 |
Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.
The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |||||
Dr. Zelma Kiss | |||||
Calgary, Alberta, Canada, T2N 4N1 | |||||
Dr. Matt Wheatley | |||||
Edmonton, Alberta, Canada, T2G 2B7 | |||||
Canada, British Columbia | |||||
Dr. Chris Honey | |||||
Vancouver, British Columbia, Canada, V5Z 4E5 | |||||
Canada, Manitoba | |||||
Dr. Jerry Krcek | |||||
Winnipeg, Manitoba, Canada, R3C 0N2 | |||||
Canada, Ontario | |||||
Dr. Andrew Parrent | |||||
London, Ontario, Canada, N6A 5A5 |
University of Calgary |
Canadian Institutes of Health Research (CIHR) |
Calgary Health Region |
Medtronic |
Principal Investigator: | Zelma Kiss, MD | University of Calgary |
Related Info 
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Related Info 
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Study ID Numbers: | 16760 |
First Received: | August 18, 2005 |
Last Updated: | January 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00132990 |
Health Authority: | Canada: Health Canada |
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