Clinical trial NCT00132990: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
Official title: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dystonia
Keywords: Cervical dystonia
Deep brain stimulation
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Calgary Health Region
name: Medtronic
First posted: 2005-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improvement in neck postures/movements
measure: Improvement in quality of life
Secondary outcomes:
measure: Document adverse effects of surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Dr. Zelma Kiss
state: Alberta
city: Edmonton
country: Canada
facility: Dr. Matt Wheatley
state: Alberta
city: Vancouver
country: Canada
facility: Dr. Chris Honey
state: British Columbia
city: Winnipeg
country: Canada
facility: Dr. Jerry Krcek
state: Manitoba
city: London
country: Canada
facility: Dr. Andrew Parrent
state: Ontario
Study officials:
affiliation: University of Calgary
name: Zelma Kiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/brain/awm229. Epub 2007 Sep 28.