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

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ClinicalTrials.gov Identifier: NCT02662530
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mandar Jog, Western University, Canada

Tracking Information
First Submitted Date  ICMJE January 7, 2016
First Posted Date  ICMJE January 25, 2016
Last Update Posted Date February 20, 2018
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02662530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Kinematic Assessment for Determination of Botox® Injection Parameters in Cervical Dystonia
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cervical Dystonia
Intervention  ICMJE Drug: Botulinum Toxin Type A
A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined either by visual/clinical or by biomechanical analysis of dystonic movements for cervical dystonia therapy in neck and shoulder muscles every 12 weeks over 30 weeks. BoNT-A dose will range from 50-300 U.
Other Names:
  • Botox
  • onabotulinumtoxinA
Study Arms
  • Active Comparator: Botulinum toxin type A clinical
    Initial and optimization of BoNT-A injection parameters will be conducted by clinical visual assessment
    Intervention: Drug: Botulinum Toxin Type A
  • Active Comparator: Botulinum toxin type A kinematic
    Initial and optimization of BoNT-A injection parameters will be conducted by kinematic assessment
    Intervention: Drug: Botulinum Toxin Type A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date January 2020
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consenting male and female individuals between the ages of 18 and 80
  • Diagnosed with idiopathic spasmodic torticollis (also called cervical dystonia) by neurologist
  • Botulinum neurotoxin type A injection(BoNT A; Botox®) naïve individuals will be randomized into either clinical-assessment arm or kinematic-assessment arm and the participants will be blinded to which arm they are a part of
  • CD individuals who are receiving suboptimal BoNT-A effects will be recruited to receive kinematic-based injections. These participants will have to wait a minimum of 4 months before participating in this study
  • Able to attend all study sessions
  • Able to provide written consent

Exclusion Criteria:

  • Pregnant individuals
  • Women who are nursing
  • Individuals with a known Botox® allergy
  • Individuals with a known or suspected traumatic cause for the torticollis, a prior thalamotomy, or peripheral (nerve or muscle) operation
  • Individuals with cervical contractures that limit passive range of motion
  • Motor/nerve diseases such as myasthenia gravis, other diseases of the neuromuscular junction and/or Amyotrophic Lateral Sclerosis
  • Myotomy or denervation surgery involving the neck or shoulder region
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Mandar Jog, MD 519-685-8500 ext 32758 mandar.jog@lhsc.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02662530
Other Study ID Numbers  ICMJE 105515
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mandar Jog, Western University, Canada
Study Sponsor  ICMJE Western University, Canada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mandar Jog, MD London Health Sciences Centre
PRS Account Western University, Canada
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP