Bilateral Essential Tremor Treatment With FUS

NCT ID: NCT04501484

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel).

Group Type: EXPERIMENTAL

Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy

Intervention Type: PROCEDURE

Ablation of contralateral VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients must be ≥ 18 years
• The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist;
• The patient previously underwent a MRgFUS (> 6 months ago);
• The tremor on the untreated side negatively impacts the patients' quality of life;
• The patient wants treatment of the contralateral side.

Exclusion Criteria

• Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use)
• Clinically relevant speech impairment (e.g. impairment of intelligibility)
• Inability to comply with the follow-up schedule;
• Refusal of the treating physician.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Andres M. Lozano

Neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres Lozano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

20-5172

Identifier Type: -

Identifier Source: org_study_id