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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 weeks

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

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

Torticollis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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