NCT04501484

Bilateral Essential Tremor Treatment With FUS

Bilateral Essential Tremor Treatment With Magnetic Resonance-guided Focused Ultrasound

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
PROCEDURE	Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy	Ablation of contralateral VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel)

Timeline

• Start date: 2020-07-08
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-08-06
• Last updated: 2024-05-08

Locations

1 site across 1 country: Canada