Clinical Trial: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: University of Calgary
Current Primary Outcome:
- Improvement in neck postures/movements
- Improvement in quality of life
Original Primary Outcome:
- Improvement in neck postures/movements
- Improvement of quality of life
Current Secondary Outcome: Document adverse effects of surgery
Original Secondary Outcome: Same as current
Information By: University of Calgary
Dates:
Date Received: August 18, 2005
Date Started: February 2003
Date Completion: September 2005
Last Updated: January 11, 2007
Last Verified: January 2007
