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

Western University, Canada

Status and phase

Unknown

Phase 2

Conditions

Cervical Dystonia

Treatments

Drug: Botulinum Toxin Type A

Study type

Interventional

Funder types

Other

Identifiers

NCT02662530

105515

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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