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A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by University of Calgary.
Recruitment status was:  Active, not recruiting
Canadian Institutes of Health Research (CIHR)
Calgary Health Region
Information provided by:
University of Calgary Identifier:
First received: August 18, 2005
Last updated: January 11, 2007
Last verified: January 2007

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.

Condition Intervention
Cervical Dystonia
Device: Deep brain stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia

Resource links provided by NLM:

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Improvement in neck postures/movements
  • Improvement in quality of life

Secondary Outcome Measures:
  • Document adverse effects of surgery

Estimated Enrollment: 10
Study Start Date: February 2003
Estimated Study Completion Date: September 2005
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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00132990

Canada, Alberta
Dr. Zelma Kiss
Calgary, Alberta, Canada, T2N 4N1
Dr. Matt Wheatley
Edmonton, Alberta, Canada, T2G 2B7
Canada, British Columbia
Dr. Chris Honey
Vancouver, British Columbia, Canada, V5Z 4E5
Canada, Manitoba
Dr. Jerry Krcek
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Ontario
Dr. Andrew Parrent
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Calgary Health Region
Principal Investigator: Zelma Kiss, MD University of Calgary
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00132990     History of Changes
Other Study ID Numbers: 16760
Study First Received: August 18, 2005
Last Updated: January 11, 2007

Keywords provided by University of Calgary:
Cervical dystonia
Deep brain stimulation

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases processed this record on April 28, 2017