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Procedure
Focused Ultrasound Thalamotomy for Essential Tremor (BEST-FUS Trial)
N/A
Recruiting
Led By Andres Lozano, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post operative month 1, 3, 12, 24, 36
Awards & highlights
BEST-FUS Trial Summary
This trial is testing a new treatment for essential tremor, which is a movement disorder. The trial is comparing the new treatment to no treatment, and is looking at side effects, how well it works, and quality of life.
Who is the study for?
This trial is for adults over 18 who have essential tremor and previously had successful MRgFUS thalamotomy on one side. They must want treatment for the other side, with a neurologist-confirmed diagnosis of ET or ET plus, and their quality of life should be affected by the tremor.Check my eligibility
What is being tested?
The study tests if focused ultrasound thalamotomy can safely treat essential tremor in the untreated brain hemisphere. Initially, 10 patients will undergo this procedure; if safe, an additional 40 will join. The main goal is to see how much it improves their tremors after a year.See study design
What are the potential side effects?
Potential side effects include issues related to the nervous system like speech problems or balance difficulties. These will be monitored closely at several points post-treatment up to three years.
BEST-FUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Essential Tremor by a specialist.
Select...
I had MRgFUS treatment over 6 months ago.
Select...
I am 18 years old or older.
BEST-FUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post operative month 1, 3, 12, 24, 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post operative month 1, 3, 12, 24, 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in QUEST Score
Patient-based Assessment of Utility
Secondary outcome measures
Dysgeusia
Falls
Gait Assessment (NRS-11)
+8 moreBEST-FUS Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel).
Find a Location
Who is running the clinical trial?
Université de SherbrookeOTHER
292 Previous Clinical Trials
69,391 Total Patients Enrolled
1 Trials studying Essential Tremor
50 Patients Enrolled for Essential Tremor
University Health Network, TorontoLead Sponsor
1,474 Previous Clinical Trials
484,992 Total Patients Enrolled
2 Trials studying Essential Tremor
75 Patients Enrolled for Essential Tremor
Andres Lozano, MD, PhDPrincipal InvestigatorUniversity of Toronto
2 Previous Clinical Trials
53 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I want treatment for the opposite side of my initial condition.My tremor on one side is affecting my daily life.I have been diagnosed with Essential Tremor by a specialist.I have trouble being understood when I speak.I have trouble walking or balancing, and may use a wheelchair, walker, or cane.My doctor has advised against me joining this trial.I had MRgFUS treatment over 6 months ago.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling new participants in this clinical trial?
"Clinicaltrials.gov indicates that this study is actively recruiting participants, having been posted on July 8th 2020 and updated as recently as May 16th 2022."
Answered by AI
What are the ambitions of this research endeavor?
"This 12-month study intends to evaluate Patient-based Assessment of Utility. Supplementary objectives include examining Dysgeusia (taste alteration), Gait Assessment using an NRS-11 rating system, and Tremor according to the Clinical Rating Scale for Tremor (CRST)."
Answered by AI
What is the total cohort of participants in this clinical trial?
"Affirmative. According to the clinicaltrials.gov portal, this research is currently enrolling patients with a start date of July 8th 2020 and an update on May 16th 2022. 50 participants are being recruited from one medical centre for participation in this trial."
Answered by AI
Who else is applying?
What site did they apply to?
Toronto Western Hospital, University Health Network
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Recent research and studies
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