Clinical Trial: A Multicentre Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia

This study is no longer recruiting patients.

Sponsors and Collaborators: University of Calgary
Canadian Institute for Health Research
Calgary Health Region
Medtronic Canada
Information provided by: University of Calgary
ClinicalTrials.gov Identifier: NCT00132990

Purpose

To determine if bilateral pallidal deep brain stimulation results in improvement in (i) neck postures/movements (ii) quality of life, and (iii)to document the adverse effects of surgery in patients with cervical dystonia.
Condition Intervention
Cervical dystonia
 Device: Deep brain stimulation

MedlinePlus related topics:  Dystonia

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia

Further Study Details: 
Primary Outcomes: Improvement in neck postures/movements; Improvement of quality of life
Secondary Outcomes: Document adverse effects of surgery
Expected Total Enrollment:  10

Study start: February 2003;  Study completion: November 2005
Last follow-up: September 2005;  Data entry closure: October 2005

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 plain is that of 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.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Adult patients male or female
  • Diagnosed with cervical dystonia by a movement disorders neurologist
  • Only has cervical dystonia alone, not generalized or multifocal
  • Had had adequate trials of medical therapy

Exclusion Criteria:

  • Cognitive impairment
  • Abnormalities on pre-operative MRI
  • Medical conditions precluding general anaesthetic or surgery
  • Unstable psychiatric disease
  • Previous brain lesions to treat cervical dystonia

Location Information


Canada, Alberta
      Dr. Zelma Kiss, Calgary,  Alberta,  T2N 4N1,  Canada

      Dr. Matt Wheatley, Edmonton,  Alberta,  T2G 2B7,  Canada

Canada, British Columbia
      Dr. Chris Honey, Vancouver,  British Columbia,  V5Z 4E5,  Canada

Canada, Manitoba
      Dr. Jerry Krcek, Winnipeg,  Manitoba,  R3C 0N2,  Canada

Canada, Ontario
      Dr. Andrew Parrent, London,  Ontario,  N6A 5A5,  Canada

Study chairs or principal investigators

Zelma Kiss, MD,  Principal Investigator,  University of Calgary   

More Information

Study ID Numbers:  16760
Last Updated:  August 19, 2005
Record first received:  August 18, 2005
ClinicalTrials.gov Identifier:  NCT00132990
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13

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