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Bilateral Essential Tremor Treatment With Gamma Knife

Study acronym: BEST-GK
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 17, 2021 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2021 to Jun 8, 2021
    • Site details revised at 2 of 2 sites
    v4
  2. Start date: Feb 2021 to May 2021v3
  3. Secondary endpoints: details revised at 1 of 11 entriesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04748640
Lead Sponsor Université de Sherbrooke
Collaborators: University Health Network, Toronto
Conditions
(from sponsor)		 Essential Tremor
Related terms Central Nervous System Diseases, Dyskinesias, Essential Tremor, Movement Disorders, Nervous System Diseases, Neurologic Manifestations, Tremor
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov