Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02668497
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mandar Jog, Western University, Canada

Brief Summary:
The primary objective is to study the efficacy of botulinum toxin type A (BoNT-A) injected via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past clinical studies will be used in determining injection parameters. The objective is to study the composition of PD tremor using kinematic tools which may contribute to the knowledge of tremor complexity and contribute information that would benefit the development of injection parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators believe a greater improvement in Quality of Life on more daily tasks can be achieved compared to the investigator's earlier study in unilateral injections (REB#101749), which already showed significant improvement.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Botulinum Toxin Type A Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy
Actual Study Start Date : March 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: De-novo PD
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 by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 72 weeks. BoNT-A dose will range from 50-300 U per arm
Drug: Botulinum Toxin Type A
Other Names:
  • IncobotulinumtoxinA
  • BoNT-A

Experimental: L-dopa PD
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 by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 72 weeks. BoNT-A dose will range from 50-300 U per arm
Drug: Botulinum Toxin Type A
Other Names:
  • IncobotulinumtoxinA
  • BoNT-A




Primary Outcome Measures :
  1. Kinematic tremor severity [ Time Frame: 48 weeks ]
    Change from pre to post-BoNT-A treatments in maximum angular tremor amplitude at the wrist in each treated arm. Angular tremor amplitude is one parameter reflecting the vectoral intensity of tremor segmented at each arm joint


Secondary Outcome Measures :
  1. Clinical tremor severity [ Time Frame: 48 weeks ]
    Improvement in upper limb tremor severity as determined by an increase >8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post BoNT-A injection using kinematic-determined injection parameters in both ET upper limbs

  2. Accelerometric kinematic tremor severity [ Time Frame: 48 weeks ]
    Change from pre and post-BoNT-A treatments in maximum log-transformed accelerometric tremor amplitude at wrist level (injected limb). Log-transformed accelerometric tremor amplitude is one parameter reflecting the non-vectoral intensity of tremor.

  3. Quality of life measures [ Time Frame: 48 weeks ]
    Quality of life for essential tremor questionnaire is used to measure the patient's impression of change due to treatment and its change on their quality of life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease
  • PD participants who are naïve to PD medications will be grouped into the "De novo" PD group
  • PD participants stable on a low dose of Levodopa or on their PD medications for at least 3 months prior to their study enrolment will be grouped into the "L-dopa" PD group
  • Participants who are botulinum toxin naïve for tremor management
  • Patients will be screened for pregnancy by the physician
  • Individuals with PD will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report denoting tremor-dominant phenotype
  • Participants must be able to provide informed consent and to complete all study assessment scales and tasks.

Exclusion Criteria:

  • History of stroke
  • History of ALS or Myasthenia Gravis
  • History of COPD or emphysema
  • Underlying arm muscle weakness or any related compartmental muscle syndrome
  • Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol).
  • Persons prescribed zonisamide
  • History of allergic or side effect reaction to botulinum toxin
  • Contraindications per the BoNT-A drug monograph
  • Women reporting that they are pregnant

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): NCT02668497


Locations
Layout table for location information
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Western University, Canada
Investigators
Layout table for investigator information
Principal Investigator: Mandar Jog, MD LHSC

Publications:

Layout table for additonal information
Responsible Party: Mandar Jog, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT02668497     History of Changes
Other Study ID Numbers: 107433
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Keywords provided by Mandar Jog, Western University, Canada:
Movement disorders
Botulinum toxin type A
Tremor
Kinematics
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
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