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Neurotoxin

Botulinum toxin type A clinical for Cervical Dystonia

Phase 2
Waitlist Available
Led By Mandar Jog, MD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with idiopathic spasmodic torticollis (also called cervical dystonia) by neurologist
Consenting male and female individuals between the ages of 18 and 80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 weeks
Awards & highlights

Study 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.

Eligible Conditions
  • Cervical Dystonia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course
Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course
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.
Number of participants with significant relief of severity by global impression of change scores over treatment course

Trial Design

2Treatment groups
Active Control
Group I: Botulinum toxin type A clinicalActive Control1 Intervention
Initial and optimization of BoNT-A injection parameters will be conducted by clinical visual assessment
Group II: Botulinum toxin type A kinematicActive Control1 Intervention
Initial and optimization of BoNT-A injection parameters will be conducted by kinematic assessment

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor
238 Previous Clinical Trials
57,143 Total Patients Enrolled
2 Trials studying Cervical Dystonia
48 Patients Enrolled for Cervical Dystonia
Mandar Jog, MDPrincipal InvestigatorLondon Health Sciences Centre
7 Previous Clinical Trials
435 Total Patients Enrolled
1 Trials studying Cervical Dystonia
15 Patients Enrolled for Cervical Dystonia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025