Clinical Trial: Clinical and Kinematic Assessment for Determination of Botox® Injection Parameters in Cervical Dystonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Clinical and Kinematic Assessment in the Determination of Botox® Injection Parameters in Cervical Dystonia Patients

Brief Summary: This study investigates the use of a kinematic measurement device to quantify the abnormal head movements and postures in patients with cervical dystonia (CD) in order to individualize and optimize botulinum toxin type A (BoNT-A) injection therapy. A single sensor captures five degrees of freedom of the neck and head that distinguish which muscle(s) contribute to CD and the amount of BoNT-A to inject into these muscle(s). The efficacy, relief and improvements in social, occupation and function by injections will be investigated. The efficacy of BoNT-A therapy using either BoNT-A injection parameters from clinical-based assessments and kinematically-based assessments will be investigated in CD patients. Individuals clinically diagnosed with CD will be randomized for two treatment conditions: A) injection parameters from a kinematic assessment only, or B) injection parameters from a clinical assessment only.

Detailed Summary:
Sponsor: Western University, Canada

Current Primary Outcome:

  • Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course [ Time Frame: 30 weeks ]
    Physiological changes as a result of BoNT-A injection treatment will be assessed by validated CD assessment scale, TWSTRS part A for severity and C for pain, will be administered at each time-point to determine efficacy of using BoNT-A parameters based on clinical versus kinematics.
  • Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course [ Time Frame: 30 weeks ]
    Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course. Physiological changes in static/natural neck and head posturing, dynamic/tremor/dystonic movements superimposed on natural head position, range of motion will be assessed kinematically at each time-point. Angular deviations are calculated by degree of freedom angular bias from calibrated neutral position. Amplitude measures will be reported as root mean square values.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with significant improvement in functional disability scores assessed by TWSTRS part B and patient-reported scores pre- and post-BoNT-A parameters determined visually or kinematically. [ Time Frame: 30 weeks ]
    Change in functional disability, quality of life and relief of pain as a result of BoNT-A injection treatment will be measured will be measured by comparing pre- and post-injection TWSTRS.
  • Number of participants with significant relief of severity by global impression of change scores over treatment course [ Time Frame: 30 weeks ]
    Number of participants with significant relief of severity and pain by global impression of change scores over treatment course. This scale is a self-reported by participant on a VAS/Likert scale.


Original Secondary Outcome: Same as current

Information By: Western University, Canada

Dates:
Date Received: January 7, 2016
Date Started: February 2016
Date Completion: January 2018
Last Updated: October 31, 2016
Last Verified: October 2016