NCT00132990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2003

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

May 20, 2019

Status Verified

January 1, 2007

First QC Date

August 18, 2005

Last Update Submit

May 17, 2019

Conditions

Cervical Dystonia

Keywords

Cervical dystoniaDeep brain stimulation

Outcome Measures

Primary Outcomes (2)

  • Improvement in neck postures/movements

  • Improvement in quality of life

Secondary Outcomes (1)

  • Document adverse effects of surgery

Interventions

Deep brain stimulationDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dr. Zelma Kiss

Calgary, Alberta, T2N 4N1, Canada

Location

Dr. Matt Wheatley

Edmonton, Alberta, T2G 2B7, Canada

Location

Dr. Chris Honey

Vancouver, British Columbia, V5Z 4E5, Canada

Location

Dr. Jerry Krcek

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Dr. Andrew Parrent

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 17905796DERIVED

Related Links

MeSH Terms

Conditions

Torticollis

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Zelma Kiss, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

February 1, 2003

Study Completion

September 1, 2005

Last Updated

May 20, 2019

Record last verified: 2007-01

Locations

CA(5)