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

Primary Purpose

Cervical Dystonia

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Botulinum Toxin Type A

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Botulinum toxin type A clinical

Botulinum toxin type A kinematic

Arm Description

Initial and optimization of BoNT-A injection parameters will be conducted by clinical visual assessment

Initial and optimization of BoNT-A injection parameters will be conducted by kinematic assessment

Outcomes

Primary Outcome Measures

Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course

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

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 Outcome Measures

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.

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

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.

Full Information

NCT ID

NCT02662530

First Posted

January 7, 2016

Last Updated

June 18, 2020

Sponsor

Western University, Canada

1. Study Identification

Unique Protocol Identification Number

NCT02662530

Brief Title

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University, Canada

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Dystonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum toxin type A clinical

Arm Type

Active Comparator

Arm Description

Initial and optimization of BoNT-A injection parameters will be conducted by clinical visual assessment

Arm Title

Botulinum toxin type A kinematic

Arm Type

Active Comparator

Arm Description

Initial and optimization of BoNT-A injection parameters will be conducted by kinematic assessment

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A

Other Intervention Name(s)

Botox, onabotulinumtoxinA

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course

Description

Time Frame

30 weeks

Title

Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course

Description

Time Frame

30 weeks

Secondary Outcome Measure Information:

Title

Description

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.

Time Frame

30 weeks

Title

Number of participants with significant relief of severity by global impression of change scores over treatment course

Description

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.

Time Frame

30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mandar Jog, MD

Organizational Affiliation

London Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A5A5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

8780093

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.

Results Reference

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PubMed Identifier

19154335

Citation

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.

Results Reference

background

PubMed Identifier

20590814

Citation

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.

Results Reference

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PubMed Identifier

25186131

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.

Results Reference

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PubMed Identifier

25414799

Citation

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.

Results Reference

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PubMed Identifier

21636319

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.

Results Reference

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PubMed Identifier

16799694

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. Erratum In: Biol Proced Online. 2006;8:163.

Results Reference

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

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