Cervical Dystonia Clinical Trial
Official title:
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Phase 2 | |
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N/A | |
| Completed |
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||
| Completed |
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Phase 1/Phase 2 | |
| Completed |
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Phase 3 | |
| Completed |
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||
| Recruiting |
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|
Phase 4 | |
| Completed |
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|
Phase 3 | |
| Completed |
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||
| Completed |
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|
Phase 4 | |
| Completed |
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Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
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Phase 3 | |
| Completed |
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| Terminated |
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Phase 2 | |
| Completed |
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N/A | |
| Completed |
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Phase 1 | |
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Phase 2 |