Trials / Completed
CompletedNCT00132990
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (planned)
- Sponsor
- University of Calgary · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Deep brain stimulation |
Timeline
- Start date
- 2003-02-01
- Completion
- 2005-09-01
- First posted
- 2005-08-22
- Last updated
- 2019-05-20
Locations
5 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00132990. Inclusion in this directory is not an endorsement.