Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

Western University, Canada

Status and phase: Unknown; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02668497

107433

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

De-novo PD

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxin Type A

L-dopa PD

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxin Type A