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

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.

Timeline

Start

2012-01

Primary completion

2020-12

Completion

2021-01

Publications

• Background 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.
• Background Caleo M, Antonucci F, Restani L, Mazzocchio R. A reappraisal of the central effects of botulinum neurotoxin type A: by what mechanism? J Neurochem. 2009 Apr;109(1):15-24. doi: 10.1111/j.1471-4159.2009.05887.x. Epub 2009 Feb 11.
• Background Dressler D. Botulinum toxin for treatment of dystonia. Eur J Neurol. 2010 Jul;17 Suppl 1:88-96. doi: 10.1111/j.1468-1331.2010.03058.x.
• Background 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.
• Background Evidente VG, Pappert EJ. Botulinum toxin therapy for cervical dystonia: the science of dosing. Tremor Other Hyperkinet Mov (N Y). 2014 Nov 12;4:273. doi: 10.7916/D84X56BF. eCollection 2014.
• Background 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.
• Background 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.

Drugs

Indications