A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
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|ClinicalTrials.gov Identifier: NCT00132990|
Recruitment Status : Unknown
Verified January 2007 by University of Calgary.
Recruitment status was: Active, not recruiting
First Posted : August 22, 2005
Last Update Posted : January 12, 2007
The purposes of this study are:
- to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
- to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
- to document the adverse effects of surgery in patients with cervical dystonia.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Dystonia||Device: Deep brain stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia|
|Study Start Date :||February 2003|
|Study Completion Date :||September 2005|
- Improvement in neck postures/movements
- Improvement in quality of life
- Document adverse effects of surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132990
|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|
|Dr. Jerry Krcek|
|Winnipeg, Manitoba, Canada, R3C 0N2|
|Dr. Andrew Parrent|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Zelma Kiss, MD||University of Calgary|