Clinical trial NCT02551848: Kinematic-based BoNT-A Injections for Bilateral ET
Official title: Botulinum Toxin Type A for Injection of Bilateral Upper Extremity Tremor in Patients With Essential Tremor Using Kinematic Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Essential Tremor
Keywords: Movement disorders
Botulinum toxin type A
Kinematics
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Kinematic tremor severity
timeFrame: 72 weeks
Secondary outcomes:
measure: Clinical tremor severity
timeFrame: 72 weeks
measure: Accelerometric kinematic tremor severity
timeFrame: 72 weeks
measure: Quality of life measures
timeFrame: 72 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: LHSC
name: Mandar Jog, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Adler CH, Bansberg SF, Hentz JG, Ramig LO, Buder EH, Witt K, Edwards BW, Krein-Jones K, Caviness JN. Botulinum toxin type A for treating voice tremor. Arch Neurol. 2004 Sep;61(9):1416-20. doi: 10.1001/archneur.61.9.1416.
citation: Zesiewicz TA, Elble R, Louis ED, Hauser RA, Sullivan KL, Dewey RB Jr, Ondo WG, Gronseth GS, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: therapies for essential tremor [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005 Jun 28;64(12):2008-20. doi: 10.1212/01.WNL.0000163769.28552.CD. Epub 2005 Jun 22.