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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

Must not have

Refusal of the treating physician

Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post operative month 3, 6, 12, 24, 36

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

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I have been diagnosed with Essential Tremor by a specialist.

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I have been diagnosed with Essential Tremor by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor has advised against me joining the trial.

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I have trouble walking or balancing, and may use a wheelchair, walker, or cane.

Select...

I have trouble being understood when I speak.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post operative month 3, 6, 12, 24, 36

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in QUEST Score

Patient-based Assessment of Utility

Secondary study objectives

Dysgeusia

Falls

Gait Assessment (NRS-11)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 7Eligibility criteria met