RecruitingNAINTERVENTIONAL

EMBRACE Tremor BiFUS

This study, called EMBRACE Tremor BiFUS, is for people with Essential Tremor who have already had one Exablate treatment on one side of their brain. The main aim is to see if having a second Exablate treatment on the other side of the brain works better to reduce tremors than simply continuing with their usual medical care. Researchers will compare tremor improvement, how well people can do daily activities, their quality of life, and any side effects over six months. This will help understand if this two-stage treatment offers extra benefits to patients.

At a glance

Status

Recruiting

Phase

Sponsor

InSightec

Enrolment target

100

Start

22 Apr 2025

Estimated completion

01 Jan 2028

Essential Tremor

What is this study about?

This research study, called EMBRACE Tremor BiFUS, is looking into a treatment for Essential Tremor. You might know Essential Tremor as a condition that causes shakey hands, head, or voice. If you've already had a special brain treatment called Exablate thalamotomy on one side of your brain for your tremors, this study might be for you. The study wants to find out if having a second Exablate treatment on the *other* side of your brain is more helpful than sticking with the medical treatments you're already receiving.

Exablate thalamotomy is a way to treat tremors using focused sound waves, and it doesn't involve surgery in the traditional sense. Many people find their tremors improve after one of these treatments. This study is trying to understand if a second treatment, carefully planned after the first, can lead to even better results without introducing too many new risks. Researchers will be comparing people who get the second treatment with those who continue with their usual medical care after their first Exablate procedure.

The main things the study will measure are how much your tremors improve, how much easier it is for you to do everyday tasks, and how your overall quality of life changes. They will also keep a close eye on any side effects and how you feel about the treatment results. This research is important because it could help doctors understand the best way to treat Essential Tremor for people who might benefit from more than one Exablate treatment.

Key takeaways

Study for people with Essential Tremor who've already had one Exablate brain treatment.
Compares having a second Exablate treatment vs. continuing usual medical care.
Aims to see if a second treatment further reduces tremors and improves quality of life.
Participation involves being randomly assigned to a group and attending follow-up appointments.
Study lasts at least 6 months, monitoring tremor, daily function, and any side effects.
Your decision to join or leave the study won't affect your regular medical care.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. You must have Essential Tremor and have already had a one-sided Exablate treatment at least nine months ago. Importantly, you should be a good candidate for a second Exablate treatment on the other side of your brain.

There are also some practical requirements: you need to be able to have scans like CT and MRI and be able to tell the doctor how you're feeling during the treatment, as you wouldn't be under general anaesthetic. You also need to be comfortable in an MRI machine and able to lie still. You also can't have had any major new nerve problems or worsening symptoms that weren't temporary after your first Exablate procedure.

Several things would mean you can't take part. This includes having certain metal implants in your body that aren't safe for MRI scans, having active infections, brain tumours, or bleeding problems in the brain. If you're not able to have your head shaved, or if you have severe claustrophobia that medicine doesn't help with, you also wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Essential Tremor and have you already had one Exablate treatment at least 9 months ago?
Are you able to have MRI and CT scans and fit comfortably in an MRI machine?
Are you generally in good health, without active infections or certain other brain conditions?
Are you willing to have your head shaved for treatment, if you are in that group?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be asked to sign a consent form, which means you understand what's involved and agree to participate. You'll then be randomly assigned to one of two groups: either you'll receive the second Exablate treatment on the other side of your brain, or you'll continue with your usual medical care for your tremors. Neither you nor your doctor will know which group you're in (this is called 'blinded').

If you're in the treatment group, you'll undergo the second Exablate procedure. For everyone in the study, there will be several visits and assessments over a period of at least six months. These will include checks on your tremor severity, how well you can perform daily activities, and questionnaires about your quality of life. The study team will also carefully record any side effects you experience. You'll need to be available and willing to complete all these assessments for the full six months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of further tremor reduction and improved quality of life if the two-stage Exablate treatment proves more effective. However, as with any medical procedure, there are potential risks, such as side effects from the Exablate treatment. The study will carefully monitor these side effects. If you're in the control group, you wouldn't have the second Exablate treatment, so you wouldn't have the risks associated with that specific procedure, but you also might not get the potential benefits. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Turku University Hospital
Verified postcode
Turku, Finland· Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
Verified postcode
Kiel, Germany· Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Verified postcode
Milan, Italy· Recruiting
Germans Trias i Pujol Hospital
Verified postcode
Badalona, Spain· Recruiting
HM CINAC- Hospital Universitario HM Puerta del Sur
Verified postcode
Móstoles, Spain· Recruiting
Clinica Universidad de Navarra
Verified postcode
Pamplona, Spain· Recruiting
Ascires Hospital_ECG Salud
Verified postcode
Valencia, Spain· Active not recruiting
The Walton Center
Verified postcode
Liverpool, United Kingdom· Not yet recruiting

Common questions

What is Exablate thalamotomy?

It's a non-surgical treatment that uses focused sound waves to treat tremors. It targets a small area in the brain to help reduce shaking.

What does 'staged bilateral' mean?

It means the treatment is done in two stages, on both sides of the brain, but at different times – not at the same time.

Will I know if I'm getting the second treatment or not?

No, this is a 'blinded' study, meaning neither you nor your doctor will know which group you are in until after the study has finished.

How long will I be involved in the study?

You'll be involved for at least six months, during which time you'll have specific check-ups and assessments.

Can I stop being part of the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any point, and your decision won't affect your future medical care.

How to find out more

Pascalle Reiters

pascaller@insightec.com +31 653726776 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.