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

Cervical Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132990
• Other study ID #: 16760
• Status: Completed
• Phase: N/A
• Start date: February 2003
• Est. completion date: September 2005

Study information

• Verified date: January 2007
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Device:
• Deep brain stimulation

Locations

Country	Name	City	State
Canada	Dr. Zelma Kiss	Calgary	Alberta
Canada	Dr. Matt Wheatley	Edmonton	Alberta
Canada	Dr. Andrew Parrent	London	Ontario
Canada	Dr. Chris Honey	Vancouver	British Columbia
Canada	Dr. Jerry Krcek	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Calgary Health Region, Canadian Institutes of Health Research (CIHR), Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in neck postures/movements
Primary	Improvement in quality of life
Secondary	Document adverse effects of surgery

External Links

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