Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132990
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2005-08-18
Brief Title:
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are
to determine if bilateral pallidal deep brain stimulation results in improvement in neck posturesmovements
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
to determine if bilateral pallidal deep brain stimulation results in improvement in neck posturesmovements
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None