Clinical trial NCT02662530: Clinical and Kinematic Assessment for Determination of Botox® Injection Parameters in Cervical Dystonia
Official title: Comparison of Clinical and Kinematic Assessment in the Determination of Botox® Injection Parameters in Cervical Dystonia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Dystonia
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course
timeFrame: 30 weeks
measure: Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course
timeFrame: 30 weeks
Secondary outcomes:
measure: 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.
timeFrame: 30 weeks
measure: Number of participants with significant relief of severity by global impression of change scores over treatment course
timeFrame: 30 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Mandar Jog, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brans JW, Lindeboom R, Snoek JW, Zwarts MJ, van Weerden TW, Brunt ER, van Hilten JJ, van der Kamp W, Prins MH, Speelman JD. Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial. Neurology. 1996 Apr;46(4):1066-72. doi: 10.1212/wnl.46.4.1066.
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citation: Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin(R)) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014 Nov 15;346(1-2):116-20. doi: 10.1016/j.jns.2014.08.004. Epub 2014 Aug 10.
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citation: Werdelin L, Dalager T, Fuglsang-Frederiksen A, Regeur L, Karlsborg M, Korbo L, Munck O, Winge K. The utility of EMG interference pattern analysis in botulinum toxin treatment of torticollis: a randomised, controlled and blinded study. Clin Neurophysiol. 2011 Nov;122(11):2305-9. doi: 10.1016/j.clinph.2011.04.012. Epub 2011 Jun 1.
citation: Raez MB, Hussain MS, Mohd-Yasin F. Techniques of EMG signal analysis: detection, processing, classification and applications. Biol Proced Online. 2006;8:11-35. doi: 10.1251/bpo115. Epub 2006 Mar 23.