This trial is active, not recruiting.

Condition cervical dystonia
Treatment deep brain stimulation
Sponsor University of Calgary
Collaborator Canadian Institutes of Health Research (CIHR)
Start date February 2003
End date September 2005
Trial size 10 participants
Trial identifier NCT00132990, 16760


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Improvement in neck postures/movements
time frame:
Improvement in quality of life
time frame:

Secondary Outcomes

Document adverse effects of surgery
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
Principal investigator Zelma Kiss, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by University of Calgary.