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Procedure

Gamma Knife Treatment for Essential Tremor (BEST-GK Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient previously underwent a GK thalamotomy (> 12 months ago);
Patients must be ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post operative month 3, 6, 12, 24, 36
Awards & highlights

BEST-GK Trial Summary

This trial is testing a new treatment for essential tremor, which is a disorder that causes shaking. The trial is comparing the new treatment to the standard treatment, and is looking at things like quality of life and adverse events to see which is better.

Who is the study for?
This trial is for adults over 18 with essential tremor or ET plus, diagnosed by a specialist. They must have had successful Gamma Knife thalamotomy on one side over a year ago and now seek treatment for the other side due to life quality impact.Check my eligibility
What is being tested?
The study tests Gamma Knife VIM thalamotomy's effectiveness and safety in treating the opposite brain side in patients who've already undergone this procedure. It starts as Phase II with ten patients, potentially expanding to Phase III with forty more after safety review.See study design
What are the potential side effects?
Side effects will be monitored post-treatment using CTCAE v5 standards. Potential risks may include changes in gait, speech impairments, or other complications related to Gamma Knife surgery.

BEST-GK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a GK thalamotomy procedure more than a year ago.
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I am 18 years old or older.
Select...
I have been diagnosed with Essential Tremor by a specialist.
Select...
I have been diagnosed with Essential Tremor by a specialist.

BEST-GK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post operative month 3, 6, 12, 24, 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post operative month 3, 6, 12, 24, 36 for reporting.

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 more

BEST-GK Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Participants will undergo a thalamotomy contralateral to their previous treatment with Gamma Knife using a frame-based, Gamma Knife Perfexion or Icon unit (Elekta, Stockholm, Sweden).

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
292 Previous Clinical Trials
69,391 Total Patients Enrolled
1 Trials studying Essential Tremor
50 Patients Enrolled for Essential Tremor
University Health Network, TorontoOTHER
1,473 Previous Clinical Trials
484,955 Total Patients Enrolled
2 Trials studying Essential Tremor
75 Patients Enrolled for Essential Tremor

Media Library

Gamma Knife VIM thalamotomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04748640 — Phase 2 & 3
Essential Tremor Research Study Groups: Treatment group
Essential Tremor Clinical Trial 2023: Gamma Knife VIM thalamotomy Highlights & Side Effects. Trial Name: NCT04748640 — Phase 2 & 3
Gamma Knife VIM thalamotomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748640 — Phase 2 & 3

Frequently Asked Questions

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

How many research participants will be enrolled in this clinical trial?

"Yes. This trial, which was posted on June 8th, 2021, and updated on November 8th, 2021, is still recruiting patients. So far, they have 50 enrollees across 2 sites."

Answered by AI

Can anyone sign up for this drug trial right now?

"Yes, the trial is still open and accepting patients. The listing was first posted on June 8th, 2021, with the most recent update coming on November 8th, 2021."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Toronto Western Hospital, University Health Network
Recent research and studies
clinicaltrials.govStudy
Bilateral Essential Tremor Treatment With Gamma Knife
Christian Iorio-Morin 2021. "Bilateral Essential Tremor Treatment With Gamma Knife". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04748640.
All > Essential Tremor
~19 spots leftby Feb 2026
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