A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia focused on measuring Cervical dystonia, Deep brain stimulation
Eligibility Criteria
Inclusion Criteria: Adult patients, male or female Diagnosed with cervical dystonia by a movement disorders neurologist Has cervical dystonia alone, not generalized or multifocal Has had adequate trials of medical therapy Exclusion Criteria: Cognitive impairment Abnormalities on pre-operative magnetic resonance imaging (MRI) Medical conditions precluding general anaesthetic or surgery Unstable psychiatric disease Previous brain lesions to treat cervical dystonia
Sites / Locations
- Dr. Zelma Kiss
- Dr. Matt Wheatley
- Dr. Chris Honey
- Dr. Jerry Krcek
- Dr. Andrew Parrent
Outcomes
Primary Outcome Measures
Improvement in neck postures/movements
Improvement in quality of life
Secondary Outcome Measures
Document adverse effects of surgery
Full Information
NCT ID
NCT00132990
First Posted
August 18, 2005
Last Updated
May 17, 2019
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Calgary Health Region, Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00132990
Brief Title
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
Official Title
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Calgary Health Region, Medtronic
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
Cervical dystonia, Deep brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Primary Outcome Measure Information:
Title
Improvement in neck postures/movements
Title
Improvement in quality of life
Secondary Outcome Measure Information:
Title
Document adverse effects of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, male or female
Diagnosed with cervical dystonia by a movement disorders neurologist
Has cervical dystonia alone, not generalized or multifocal
Has had adequate trials of medical therapy
Exclusion Criteria:
Cognitive impairment
Abnormalities on pre-operative magnetic resonance imaging (MRI)
Medical conditions precluding general anaesthetic or surgery
Unstable psychiatric disease
Previous brain lesions to treat cervical dystonia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zelma Kiss, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Zelma Kiss
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Dr. Matt Wheatley
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T2G 2B7
Country
Canada
Facility Name
Dr. Chris Honey
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E5
Country
Canada
Facility Name
Dr. Jerry Krcek
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Dr. Andrew Parrent
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17905796
Citation
Kiss ZH, Doig-Beyaert K, Eliasziw M, Tsui J, Haffenden A, Suchowersky O; Functional and Stereotactic Section of the Canadian Neurosurgical Society; Canadian Movement Disorders Group. The Canadian multicentre study of deep brain stimulation for cervical dystonia. Brain. 2007 Nov;130(Pt 11):2879-86. doi: 10.1093/brain/awm229. Epub 2007 Sep 28.
Results Reference
derived
Links:
URL
http://www.medtronic.com
Description
Related Info
Learn more about this trial
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
We'll reach out to this number within 24 hrs