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

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ClinicalTrials.gov Identifier: NCT02662530
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mandar Jog, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Drug: Botulinum Toxin Type A Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Clinical and Kinematic Assessment in the Determination of Botox® Injection Parameters in Cervical Dystonia Patients
Actual Study Start Date : January 2012
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Active Comparator: Botulinum toxin type A clinical
Initial and optimization of BoNT-A injection parameters will be conducted by clinical visual assessment
Drug: Botulinum Toxin Type A
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.
Other Names:
  • Botox
  • onabotulinumtoxinA

Active Comparator: Botulinum toxin type A kinematic
Initial and optimization of BoNT-A injection parameters will be conducted by kinematic assessment
Drug: Botulinum Toxin Type A
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.
Other Names:
  • Botox
  • onabotulinumtoxinA




Primary Outcome Measures :
  1. Number of participants with significant relief of severity and pain by TWSTRS part A and C, respectively, over treatment course [ Time Frame: 30 weeks ]
    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.

  2. Number of participants with significant relief of severity by objective kinematic reductions in angular deviation and amplitude measures over treatment course [ Time Frame: 30 weeks ]
    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 :
  1. 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. [ Time Frame: 30 weeks ]
    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.

  2. Number of participants with significant relief of severity by global impression of change scores over treatment course [ Time Frame: 30 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662530


Contacts
Contact: Mandar Jog, MD 519-685-8500 ext 32758 mandar.jog@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A5A5
Contact: Mandar Jog, MD    519-685-8500 ext 32758    mandar.jog@lhsc.on.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
Principal Investigator: Mandar Jog, MD London Health Sciences Centre

Publications:

Responsible Party: Mandar Jog, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT02662530     History of Changes
Other Study ID Numbers: 105515
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents