Bilateral Essential Tremor Treatment With FUS

Essential Tremor Clinical Trial

— BEST-FUS  

Official title:

Bilateral Essential Tremor Treatment With Magnetic Resonance-guided Focused Ultrasound

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04501484
• Other study ID #: 20-5172
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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)

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Gait Assessment (NRS-11)	Patient-reported and blinded observer rating of the patient's ability to walk (Numerical rating scale (NRS-11) from 0 to 10, with 10 being best)	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Gait Assessment (missteps)	Number of missteps in a 6 m standardized tandem walk	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Falls	Number of falls in last month	Post operative month 1, 3, 12, 24, 36
Secondary	Speech Assessment (NRS-11)	Patient-reported and blinded observer rating of the patient's ability to speak (Numerical rating scale (NRS-11) from 0 to 10, with 10 being best)	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Numbness	Incidence of new-onset numbness	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Dysgeusia	Incidence of taste alterations	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Other adverse events	Incidence of other adverse events as classified in the CTCAE	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Tremor (CRST)	Assessment of tremor using the Clinical Rating Scale for Tremor (CRST) parts A (0-88) and B (0-36), higher scores correspond to a worse tremor).	Immediately after surgery, post operative month 1, 3, 12, 24, 36
Secondary	Quality of life (QUEST)	QUality of life in ESsential Tremor (QUEST) questionnaire (0-100%, higher scores correspond to a worse quality of life)	Post operative month 1, 3, 12, 24, 36
Secondary	Quality of life (CRST part C)	Part C of the Clinical Rating Scale for Tremor (CRST) (0-32, higher scores correspond to a worse quality of life)	Post operative month 1, 3, 12, 24, 36
Secondary	Health Utility (EQ-5D-5L)	Health Utility measured using the EQ-5D-5L and computed using the Canadian preference weights. Values range from 0 to 1, with 1 representing a perfect health.	Post operative month 1, 3, 12, 24, 36