Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00132990
Other study ID # 16760
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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
Est. primary completion date
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03617367 - Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) Phase 3
Not yet recruiting NCT04057911 - A Trial of Non-invasive Stimulation in Cervical Dystonia N/A
Withdrawn NCT02180139 - tDCS in Cervical Dystonia N/A
Completed NCT00541905 - Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia Phase 4
Unknown status NCT00418925 - Efficacy of Dronabinol for the Treatment of Cervical Dystonia Phase 2
Not yet recruiting NCT05715138 - Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia N/A
Completed NCT02959645 - Assessment of Brain Activities in Cervical Dystonia
Completed NCT02131467 - Safety and Tolerability of Perampanel in Cervical Dystonia Phase 1/Phase 2
Completed NCT03805152 - Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia Phase 3
Completed NCT04949594 - Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Recruiting NCT01664013 - The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients Phase 4
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00447772 - Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia Phase 3
Completed NCT05157100 - Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia Phase 4
Completed NCT00257660 - Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia Phase 3
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
Completed NCT00323765 - Plasticity in Cervical Dystonia N/A
Completed NCT04171258 - Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Phase 1
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2

External Links