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

May 17, 2019 updated by: University of Calgary

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Dr. Zelma Kiss
      • Edmonton, Alberta, Canada, T2G 2B7
        • Dr. Matt Wheatley
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E5
        • Dr. Chris Honey
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Dr. Jerry Krcek
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Dr. Andrew Parrent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in quality of life
Improvement in neck postures/movements

Secondary Outcome Measures

Outcome Measure
Document adverse effects of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)
Medtronic
Calgary Health Region

Investigators

  • Principal Investigator: Zelma Kiss, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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