Clinical and Kinematic Assessment for Determination of Botox® Injection Parameters in Cervical Dystonia
- Registration Number
- NCT02662530
- Lead Sponsor
- Western University, Canada
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum toxin type A clinical Botulinum Toxin Type A Initial and optimization of BoNT-A injection parameters will be conducted by clinical visual assessment Botulinum toxin type A kinematic Botulinum Toxin Type A Initial and optimization of BoNT-A injection parameters will be conducted by kinematic assessment
- Primary Outcome Measures
Name Time Method Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course 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.
Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course 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.
- Secondary Outcome Measures
Name Time Method 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. 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 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.
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada