Bilateral Essential Tremor Treatment With FUS

NCT04501484 | Active Not Recruiting DMC

• 1 other identifier: 20-5172
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

High-Intensity Focused Ultrasound Ablation

Outcome Measures

Primary Outcomes (2)

• Change in QUEST Score

  Difference in QUEST score between baseline and the 12-month follow-up, with statistical significance defined as p = 0.05 and a minimum clinically important difference (MCID) defined as 5

  12 months

• Patient-based Assessment of Utility

  A patient-reported assessment of utility after 12 months using the question "Knowing what you know now, would you do this treatment again?".

  12 months

Secondary Outcomes (11)

• Gait Assessment (NRS-11)

  Immediately after surgery, post operative month 1, 3, 12, 24, 36

• Gait Assessment (missteps)

  Immediately after surgery, post operative month 1, 3, 12, 24, 36

• Falls

  Post operative month 1, 3, 12, 24, 36

• Speech Assessment (NRS-11)

  Immediately after surgery, post operative month 1, 3, 12, 24, 36

• Numbness

  Immediately after surgery, post operative month 1, 3, 12, 24, 36

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Procedure: Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy

Interventions

Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy PROCEDURE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Université de Sherbrooke: collaborator

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Andres Lozano, MD, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All assessments filmed on video and scored by a blinded evaluator.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: July 8, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)