RecruitingInterventional

Pilot study of safety and efficacy of unilateral MRI-guided focused ultrasound thalamotomy in tremor-dominant Parkinson’s disease

Parkinson’s disease causes involuntary shaking, stiffness, and slow movement. For some people, standard medicines do not control their shaking, making daily tasks like eating or writing very difficult. This clinical trial at Ninewells Hospital in Dundee is testing an alternative approach called focused ultrasound. Instead of opening the skull or implanting wires, doctors use high-intensity sound waves guided by MRI images. These sound waves pass harmlessly through the skull and meet at a single point deep in the brain, heating and disabling the tiny area causing the tremor. You remain awake during the three-hour scan so the team can monitor your symptoms in real time. The goal is to reduce tremor on one side of the body by about half. Researchers want to confirm whether this non-invasive approach is safe and offers faster recovery than conventional brain surgery.

At a glance

Status

Recruiting

Sponsor

University of Dundee

Enrolment target

Start

01 May 2023

Estimated completion

01 Oct 2029

Parkinson's disease

What is this study about?

Parkinson’s disease is a condition that gradually affects how the brain controls movement. One of the most common and distressing symptoms is a resting tremor, which is an uncontrollable shaking of the hands, arms, or legs. While medications help many people manage their symptoms, some find that their tremor does not improve enough, even on high doses of medication. When medicines fail, traditional options have usually involved invasive brain surgery, such as deep brain stimulation (DBS), which requires drilling small holes in the skull and placing permanent wires and battery packs.

This trial is investigating a newer, less invasive option called MRI-guided focused ultrasound (MRgFUS). The technology works much like using a magnifying glass to focus sunlight onto a single point. Multiple beams of sound waves pass through the skull without making any cuts. When these beams converge on a tiny target inside the brain called the thalamus, they generate heat. This gently destroys the specific cluster of cells that sends faulty tremor signals, helping to quiet the shaking.

Because there is no cut to the skin or bone, recovery is usually much quicker than after traditional surgery. However, unlike DBS, focused ultrasound can currently only treat one side of the body, and the changes it makes in the brain are permanent. Focused ultrasound is not yet available as a routine NHS treatment for Parkinson’s disease in the UK. This trial aims to gather the safety and effectiveness data needed to help determine if it should become a wider treatment option in the future.

Key takeaways

Tests a non-invasive sound wave treatment for Parkinson's tremors that medicines cannot control.
No incisions, holes in the skull, or implanted hardware are required.
Aims to reduce tremor by around 50% on one side of the body.
Performed while you are awake inside an MRI scanner at Ninewells Hospital in Dundee.
Side effects can include lasting numbness, tingling, or balance problems.

Who may be eligible?

This study is designed for adults aged 30 and older who have been diagnosed with Parkinson's disease where shaking is the main and most troublesome symptom. To be considered, you must have already tried at least two standard Parkinson's medicines (including levodopa) at proper doses without getting enough relief, and your tremor must still cause significant difficulty with everyday tasks such as writing, dressing, or eating.

You must be able and willing to travel to Ninewells Hospital in Dundee for your appointments and procedure. Because the treatment requires you to lie still inside an MRI scanner for around three hours while awake, you must be able to communicate clearly with the team throughout the procedure to let them know what you are feeling.

You will not be able to take part if you have serious heart problems, such as a heart attack in the last six months, heart failure, or an unstable heart rhythm. You will also be excluded if you have very high blood pressure that is not controlled by medication, or severe speech problems that would stop you from talking with doctors during the treatment.

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.

I am aged 30 or older.
I have an established diagnosis of Parkinson's disease.
Tremor (shaking) is my main symptom and significantly interferes with daily activities.
I have tried at least two Parkinson's medicines that have not controlled my tremor.
I can comfortably speak and describe sensations during a three-hour MRI procedure.
I do not have severe, uncontrolled heart disease or severe high blood pressure.

Answer every question to see your result.

What does participation involve?

If you are referred by your specialist, you will first have a virtual consultation, followed by an in-person screening visit at Ninewells Hospital in Dundee. During this visit, doctors will review your medical history, perform physical and nerve checks, and carry out MRI and CT scans to see if your brain anatomy is suitable. If there is any chance you have metal fragments in your body or skull, a safety X-ray may also be done.

If you are eligible and decide to proceed, you will attend a treatment visit. You will give safety blood samples and then undergo the focused ultrasound procedure inside an MRI scanner. The treatment takes around three hours. You remain awake and the team will regularly test your tremor and ask how you feel as they gradually deliver short pulses of sound waves.

After the procedure, you will stay in hospital overnight. The next day, doctors will check for any side effects, take another MRI scan, and ask you to fill in a questionnaire before you head home. You will then return six months later for a final check-up, another MRI scan, and repeat questionnaires. In total, your participation lasts around six months.

Potential risks and benefits

The main hoped-for benefit is a reduction of around 50% in the tremor on the treated side of your body (usually your dominant hand), which may make everyday activities much easier. However, it will not improve tremor on the untreated side, nor is it likely to help head or voice tremors. The procedure carries risks: about 1 in 3 people experience numbness or tingling in their face or limbs, which is permanent in about half of those affected. Around 1 in 3 people experience balance problems or unsteadiness, which remains permanent in about a third of those affected. Roughly 1 in 20 people develop temporary slurred speech. Routine scans also involve a small amount of medical radiation. Taking part is entirely voluntary, and you can withdraw at any point without it affecting your standard NHS care.

Locations (1)

Ninewells Hospital
Approximate
Dundee, Scotland

Common questions

Will I have to have brain surgery with cuts or stitches?

No. Focused ultrasound does not involve any cuts to your skin or holes in your skull. The sound waves travel directly through the skull to reach the target area in the brain.

Will I be put to sleep during the procedure?

No, you will be awake. It is important that you are awake so you can talk to the medical team and test your hand movements, helping them confirm the treatment is working safely.

Can both of my hands be treated?

No. In this trial, the treatment is only applied to one side of the brain to treat tremor on the opposite side of the body, usually your dominant hand.

Is this treatment available on the NHS right now?

Focused ultrasound is not currently a standard NHS-approved treatment for Parkinson’s disease in the UK. This trial is being run to collect evidence on whether it is safe and works well enough to be considered in the future.

What happens if I change my mind after joining?

You are free to leave the study at any time. Deciding to withdraw will not affect your relationship with your medical team or the standard of care you receive.

How to find out more

Sarah Inglis

s.k.inglis@dundee.ac.uk +44 1382 383219 Official trial record

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