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Bilateral Essential Tremor Treatment With FUS — BEST-FUS  

Essential Tremor Clinical Trial

Official title:
Bilateral Essential Tremor Treatment With Magnetic Resonance-guided Focused Ultrasound

Clinical Trial Summary

Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with who previously underwent successful and uncomplicated MRgFUS thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 1 and 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 immediately after the procedure, as well as 1, 3, 12, 24 and 36 months post-operatively.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04501484
Study type Interventional
Source University Health Network, Toronto
Contact
Status Active, not recruiting
Phase N/A
Start date July 8, 2020
Completion date December 2025
View Details
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