This study protocol was approved by Western University Health Sciences Research Ethics Board (REB#18445) on March 28, 2012 as a clinical phase IIb pilot study. The power calculation provided in the ethics study protocol submission suggested a target sample size of 35 ET participants, though this calculation was based on literature which did not incorporate kinematics or any objective data for guiding BoNT-A injections for tremor. As this is an open-label pilot study with no randomization, a convenience sampling was reported for those that were screened (n = 25) and for those that participated in the study (n = 24). Additionally, the duration of the study stated in the approved protocol is for a 96-week study over thirteen study visits. However, the current results were significant at the timeline reported in the manuscript (six study visits over 38 weeks) as serial BoNT-A for upper limb tremor have been sparsely reported in this manner. Participants provided written consent to participate in this study by signing the study’s consent form. The ethics committee provided full board approval for this study protocol and consent procedure was approved as required in the consent documentation checklist, submitted with the full study protocol. Registration with a clinical trial registry was not a requirement for ethics approval to perform the study at this institution. The authors confirm that all ongoing and related trials for this drug/intervention are now registered (ClinicalTrials.gov Identifier: NCT02427646). See Fig 1 for the CONSORT flowchart and the supporting information (S2 File ) for the TREND statement checklist.
The inclusion criteria consisted of male and female participants, aged 18 to 80 years diagnosed with ET with upper limb tremor as their primary and most bothersome symptom for at least two years, incobotulinumtoxinA naïve, on stable medication management for a minimum of six months prior to study enrolment, with none withheld or adjusted during the study. At enrollment, participants were either stable on their anti-tremor medications, unable to tolerate oral medications, or unwilling to comply due to side effects. Exclusion criteria were those who had a history of stroke, contraindications per the incobotulinumtoxinA monograph, pregnancy, and existing pharmacological therapy with tremor-inducing side effects (e.g. lithium, valproate, steroids, amiodarone, or beta-adrenergic agonists such as salbutamol).
The inclusion criteria consisted of male and female participants, aged 18 to 80 years diagnosed with ET with upper limb tremor as their primary and most bothersome symptom for at least two years, incobotulinumtoxinA naïve, on stable medication management for a minimum of six months prior to study enrolment, with none withheld or adjusted during the study. At enrollment, participants were either stable on their anti-tremor medications, unable to tolerate oral medications, or unwilling to comply due to side effects. Exclusion criteria were those who had a history of stroke, contraindications per the incobotulinumtoxinA monograph, pregnancy, and existing pharmacological therapy with tremor-inducing side effects (e.g. lithium, valproate, steroids, amiodarone, or beta-adrenergic agonists such as salbutamol).
Free full text: Click here
