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

Not Applicable

Completed

• Conditions: Cervical Dystonia

• Registration Number: NCT00132990
• Lead Sponsor: University of Calgary

Brief 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.

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 Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-22
• Study Completion: 2005-09
• Status Verified: 2007-01
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in neck postures/movements
Improvement in quality of life

Secondary Outcome Measures

Name	Time	Method
Document adverse effects of surgery

Trial Locations

Locations (5)

Dr. Jerry Krcek; 🇨🇦 Winnipeg, Manitoba, Canada

Dr. Andrew Parrent; 🇨🇦 London, Ontario, Canada

Dr. Matt Wheatley; 🇨🇦 Edmonton, Alberta, Canada

Dr. Chris Honey; 🇨🇦 Vancouver, British Columbia, Canada

Dr. Zelma Kiss; 🇨🇦 Calgary, Alberta, Canada