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Procedure

MRgFUS thalamotomy for Essential Tremor

N/A
Recruiting
Led By Agessandro Abrahao, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will assess the safety and preliminary efficacy of a second MR-guided focused ultrasound thalamotomy on the naïve brain hemisphere in patients with medication-refractory essential tremor. The study will be conducted at the Focused Ultrasound Centre of Excellence at Sunnybrook Health Sciences Centre/University of Toronto.

Eligible Conditions
  • Essential Tremor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence at week 12 of new onset or significant worsening of: ataxic gait; speech impairment; cognitive impairment; contralateral weakness; patient-reported disabling sensory loss; Severe AEs related to the MRgFUS procedure.
Secondary outcome measures
Change in QUEST global score and EQ-5D from baseline to 12 weeks after MRgFUS, adjusted for baseline scores.
Change in the tremor score (Part A and B) from baseline to 12 weeks after MRgFUS thalamotomy, adjusted for baseline scores.
Other outcome measures
Change in speech intelligibility and speaking rate from baseline to 12 weeks after MRgFUS thalamotomy, adjusted for baseline scores.
Change in the subscores of neuropsychological tests and self-reported questionnaires from baseline to 12 weeks after MRgFUS thalamotomy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomyExperimental Treatment1 Intervention
Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,610 Total Patients Enrolled
Agessandro Abrahao, MD, MScPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

MRgFUS thalamotomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04720469 — N/A
Essential Tremor Research Study Groups: Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy
Essential Tremor Clinical Trial 2023: MRgFUS thalamotomy Highlights & Side Effects. Trial Name: NCT04720469 — N/A
MRgFUS thalamotomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04720469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation enrolling new participants at the moment?

"Clinicaltrials.gov states that this trial is currently recruiting volunteers, having first been posted on October 5th 2020 and last modified on May 17th 2022."

Answered by AI

What is the cap on participants for this clinical trial?

"Affirmative, clinicaltrials.gov contains information verifying that this medical experiment is currently enrolling participants. It was first published on October 5th 2020 and recently revised on May 17th 2022, with 12 volunteers being sought at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
New Jersey
How old are they?
18 - 65
What site did they apply to?
Sunnybrook Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Sunnybrook Health Sciences Centre: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
A Second Magnetic Resonance Guided Focused Ultrasound Thalamotomy for Essential Tremor
2020. "A Second Magnetic Resonance Guided Focused Ultrasound Thalamotomy for Essential Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04720469.
All > Essential Tremor
~3 spots leftby Apr 2025
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