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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University of Calgary.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Calgary Health Region
Medtronic
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00132990
First received: August 18, 2005
Last updated: January 11, 2007
Last verified: January 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132990

Locations
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
Medtronic
Investigators
Principal Investigator: Zelma Kiss, MD University of Calgary
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00132990     History of Changes
Other Study ID Numbers: 16760
Study First Received: August 18, 2005
Last Updated: January 11, 2007
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013