Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Movement disorders, Botulinum toxin type A, Tremor, Kinematics
Eligibility 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
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
De-novo PD
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 42 weeks. BoNT-A dose will range from 50-300 U per arm
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 42 weeks. BoNT-A dose will range from 50-300 U per arm