Kinematic-based BoNT-A Injections for Bilateral ET

Phase 2

• Conditions: Essential Tremor
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT02551848
• Lead Sponsor: Western University, Canada

Brief Summary

The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected utilizing kinematically-based injection parameters for the treatment of upper extremity essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment tools in determining injection parameters and to study the composition of tremor using kinematics.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22
• Primary Completion: 2020-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Consenting male and female participants
• Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
• Stable ET medication management for the 3 month duration prior to their enrollment in the study
• Participants who are botulinum toxin naïve for tremor management
• Patients will be screened for pregnancy by the physician

Exclusion Criteria

• History of stroke
• Muscle weakness or any related compartmental muscle syndrome
• Smoking
• History of ALS or Myasthenia Gravis
• 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 Xeomin® drug monograph
• Women reporting that they are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Essential tremor treatment	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. Participants will be treated by BoNT-A injections every 12 weeks over 72 weeks. BoNT-A parameters will be determined solely by biomechanical analysis of tremulous movements in both upper extremity BoNT-A dose will range from 50-300 U per arm

Primary Outcome Measures

Name	Time	Method
Kinematic tremor severity	72 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

Name	Time	Method
Clinical tremor severity	72 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 Xeomin® injection using kinematic-determined injection parameters in both ET upper limbs
Accelerometric kinematic tremor severity	72 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.
Quality of life measures	72 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.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada