A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia - Full Text View

Sponsors and Collaborators:	University of Calgary Canadian Institutes of Health Research (CIHR) Calgary Health Region Medtronic
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00132990

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

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dystonia

U.S. FDA Resources

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 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

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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. Epub 2007 Sep 28.

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

Keywords provided by University of Calgary:

Cervical dystonia
Deep brain stimulation

Study placed in the following topic categories:

Dystonic Disorders
Signs and Symptoms
Torticollis
Movement Disorders

Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Dyskinesias

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009