Cervical Dystonia
Conditions
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.
Interventions
DRUGBotulinum 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.
Sponsors
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed