Essential Tremor
Conditions
Keywords
Movement disorders, Botulinum toxin type A, Kinematics
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.
Interventions
DRUGBotulinum toxin type A
Sponsors
Western University, Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed