Kinematic-based BoNT-A Injections for Bilateral ET

Western University, Canada25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Tremor

Interventions

Botulinum toxin type ADRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

Kinematic tremor severity

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

Time frame: 72 weeks

Secondary Outcomes

Clinical tremor severity

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

Time frame: 72 weeks

Accelerometric kinematic tremor severity

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.

Time frame: 72 weeks

Quality of life measures

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.

Time frame: 72 weeks

Data from ClinicalTrials.gov

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