Focused Ultrasound for Essential Tremor

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InSightec

Must not be taking: Anticoagulants

Disqualifiers: Neurological event, Cardiac status, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called MR-guided focused ultrasound thalamotomy to determine its safety and effectiveness in reducing tremors on both sides of the brain in individuals with Essential Tremor. Essential Tremor causes uncontrollable shaking, and this trial targets those who haven't found relief with medication. Suitable candidates are individuals who have not tried this ultrasound procedure before and have a tremor that hasn't improved with medicine. Participants must communicate how they feel during the procedure. As an unphased trial, this study offers a unique opportunity for patients to explore new treatment options that may provide relief when other methods have not worked.

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 prior data suggests that this MR-guided focused ultrasound thalamotomy is safe for reducing bilateral tremor?

Research has shown that MR-guided focused ultrasound (MRgFUS) thalamotomy is generally safe for treating essential tremor. Studies have found that this treatment can quickly and effectively reduce tremor symptoms, with lasting results. In one study, patients who underwent MRgFUS on one side of the brain and later on the other side experienced successful outcomes. Another study demonstrated that the treatment works well and is safe even for patients whose tremors did not improve with medication. Overall, these findings suggest that MRgFUS is well-tolerated and safe for people with essential tremor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MR-guided focused ultrasound thalamotomy for essential tremor because it offers a non-invasive approach that differs significantly from traditional treatments like medication or deep brain stimulation. This technique uses precise ultrasound waves to target and destroy small areas of brain tissue responsible for tremors, without the need for surgical incisions. This innovative method reduces the risks and recovery time associated with more invasive procedures, potentially providing faster relief for patients. Additionally, it allows for real-time monitoring and adjustment during the procedure, which can improve precision and outcomes.

What evidence suggests that MR-guided focused ultrasound thalamotomy is effective for essential tremor?

Research has shown that MR-guided focused ultrasound thalamotomy, the treatment under study in this trial, can effectively reduce tremors in people with essential tremor. One study reported a 73% reduction in tremors five years after treatment. Another study found improvement in tremors on both sides of the body when treated separately. This procedure uses sound waves to target and alter specific areas of the brain, helping to calm the tremors. While it can be highly beneficial, some side effects, such as changes in sensation or balance, may occur. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38306635/

Effectiveness and safety of MR-guided focused ultrasound ... This study suggested that MRgFUS is effective and safe for patients with medication-resistant essential tremor, including those with very low mean SDR.

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2821255

Safety and Efficacy of Staged, Bilateral Focused ... In this open-label trial, 51 patients with essential tremor treated successfully unilaterally underwent focused ultrasound thalamotomy on the opposite side.

3. thejns.org thejns.org/view/journals/j-neurosurg/138/4/article-p1028.xml

5-year follow-up results in - Journal of Neurosurgery Unilateral MRgFUS thalamotomy demonstrates sustained and significant tremor improvement at 5 years with an overall improvement in quality-of-life measures.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1600159

A Randomized Trial of Focused Ultrasound Thalamotomy ... MRI-guided focused ultrasound thalamotomy reduced hand tremor in patients with essential tremor. Side effects included sensory and gait disturbances.

5. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-for-essential-tremor-five-year-results/

Focused Ultrasound for Essential Tremor: Five-Year Results The 40 patients who completed the follow-up at five years maintained a 73% tremor reduction. The final long-term data report from the pivotal ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000212164

Update on the Long-term Safety of Magnetic Resonance ... MRgFUS treatment results in immediate, significant, long-lasting improvements in tremor, with favorable safety profile.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40243386/

Efficacy and Safety of Magnetic Resonance-Guided ... Efficacy and Safety of Magnetic Resonance-Guided Focused Ultrasound Thalamotomy in Essential Tremor: A Systematic Review and Metanalysis.