UnknownPhase 2

Kinematic-based BoNT-A Injections for Bilateral ET

Canada25 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kinematic tremor severity

Timeframe: 72 weeks

Trial details

NCT IDNCT02551848

SponsorWestern University, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

View on ClinicalTrials.gov More Essential Tremor trials