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Bilateral Essential Tremor Treatment With Gamma Knife
Sponsor: Université de Sherbrooke
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2021-06-08
Completion Date
2026-10
Last Updated
2021-11-17
Healthy Volunteers
No
Conditions
Interventions
Gamma Knife VIM thalamotomy
Ablation of contralateral VIM nucleus of thalamus with GK using a frame-based, Gamma Knife Perfexion or Icon unit (Elekta, Stockholm, Sweden).
Locations (2)
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada