Bilateral Essential Tremor Treatment With Gamma Knife

Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with essential tremor who previously underwent successful and uncomplicated GK thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed at baseline, as well as 3, 6, 12, 24 and 36 months post-operatively.

NCT Number	NCT04748640
Lead Sponsor	Université de Sherbrooke Collaborators: University Health Network, Toronto
Conditions	Essential Tremor
Enrollment	50 participants
Start Date	2021-06-08
Primary Completion	2026-02 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2021-11-17