Focused Ultrasound for Essential Tremor

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

51 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken anticoagulants (blood thinners) within one month of the procedure.

What data supports the effectiveness of the treatment MR-guided focused ultrasound thalamotomy for essential tremor?

Research shows that MR-guided focused ultrasound thalamotomy is effective in reducing tremors in patients with essential tremor, with studies demonstrating its long-term safety and effectiveness over several years. ^{1 2 3 4 5}

Is focused ultrasound thalamotomy safe for humans?

Focused ultrasound thalamotomy has been studied for essential tremor and is generally considered safe, but some patients experienced side effects like imbalance, sensory disturbances, and speech difficulties. The size and location of the treated area can affect the likelihood of these side effects. ^{1 3 6 7 8}

How is MR-guided focused ultrasound thalamotomy different from other treatments for essential tremor?

MR-guided focused ultrasound thalamotomy is unique because it uses sound waves to target and destroy specific brain tissue without needing surgery, offering a non-invasive option for patients whose tremors do not respond to medication. ^{1 3 4 5 9}

Eligibility Criteria

This trial is for men and women aged 22 or older with Essential Tremor that hasn't improved with medication. Participants must have had a previous Exablate thalamotomy, be able to communicate during the procedure, and it should be at least 9 months since their last Exablate treatment. People with unstable heart conditions, recent neurological events, bleeding disorders, infections, certain implants, or who are pregnant/breastfeeding cannot join.

Inclusion Criteria

I am 22 years old or older.

My essential tremor does not improve with medication.

You are able to tell the doctors how you feel during the Exablate thalamotomy procedure.

Exclusion Criteria

You have a history of alcohol or drug abuse.

I have a history of bleeding disorders.

You have objects or devices implanted in your skull or brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MR-guided focused ultrasound (MRgFUS) thalamotomy procedure on both sides of the brain

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits (in-person)

Treatment Details

Interventions

• MR-guided focused ultrasound thalamotomy

Trial Overview The study tests if MR-guided focused ultrasound (MRgFUS) thalamotomy can safely and effectively reduce tremors on both sides of the brain in patients who have already undergone one such procedure before.

Participant Groups

Group I: Exablate Secondary Procedure Experimental Treatment 1 Intervention

Thalamotomy

Who Is Running the Clinical Trial?

InSightec

Lead Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Findings from Research

In a study involving 6 patients with various types of tremors, MRI-guided focused ultrasound (MRgFUS) targeting the ventro-intermedius nucleus (Vim) resulted in a significant reduction in tremor scores, with improvements sustained for up to 6 months.

While MRgFUS is a promising incision-free treatment for tremors other than essential tremor, some patients experienced transient and persistent side effects, highlighting the need for further research on its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. Fasano, A., Llinas, M., Munhoz, RP., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Four-year follow-up results of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Resonance-Guided Focused Ultrasound Thalamotomy in Essential Tremor: A Comprehensive Lesion Characterization. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor: 5-year follow-up results. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Bilateral staged magnetic resonance-guided focused ultrasound thalamotomy for the treatment of essential tremor: a case series study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: a 5-year single-center experience. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Lesion location and lesion creation affect outcomes after focused ultrasound thalamotomy. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes and Predictive Factors following Focused Ultrasound Thalamotomy for Essential Tremor. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. [2022]