Safety and Target Engagement of Transcranial Ultrasound Stimulation of the Ventral Intermediate Nucleus for Essential Tremor

Short title
VIM-TUS-ET
Study type
First-in-patient proof-of-concept study
Condition
Essential tremor
Status
Open to recruitment
Location
National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust (UCLH), London, UK
Chief Investigator
Dr Anna Latorre
Sponsor
NeuroHarmonics Ltd
Approvals and references
NHS Research Ethics Committee 26/WS/0096Trial registration ISRCTN17201632IRAS 365666

Study information

If you have essential tremor and your medication is ineffective or causing unwanted side effects, and surgery (such as deep brain stimulation or focused ultrasound ablation) isn't right for you, or you'd like to understand more before considering it, researchers at the National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust (UCLH), are recruiting participants for an early-stage research study.

About the study

Researchers are investigating whether low-intensity transcranial ultrasound stimulation (TUS) can safely reach a part of the brain involved in tremor. A specially designed helmet, worn on the head, delivers focused ultrasound pulses to the target area. No surgery, needles, radiation, or implants are involved.

This is very different from focused ultrasound ablation, which uses high-intensity ultrasound to create a permanent lesion in the brain. The device used in this study uses low-intensity ultrasound. Its effects are temporary and do not permanently alter the brain.

The study is sponsored by NeuroHarmonics.

What this study can and cannot offer

This is a proof-of-concept study. The aim is to assess whether the device is safe and well tolerated, and to look for early signs that the stimulation is reaching its target. We do not expect the study to provide lasting improvement in your tremor. Any effects on tremor during the session are expected to be temporary, and are measured to show that the stimulation is reaching the right brain area, not as a treatment.

Who can take part?

You may be eligible if you:

  • Are aged 18 to 80
  • Have a clinical diagnosis of essential tremor lasting at least 3 years
  • Have tremor affecting both arms
  • Have found that tremor medications such as propranolol or primidone do not adequately control your symptoms, cause intolerable side effects, or you prefer not to take them
  • Have not had previous surgical treatment for tremor (deep brain stimulation, thalamotomy, or focused ultrasound ablation)

What does taking part involve?

Three visits over 2–4 weeks:

  1. Screening visit with brain MRI scan (~90 minutes)
  2. Intervention session (~2.5–3 hours)
  3. Follow-up phone call the next day (~30 minutes)

To reimburse you for your time and travel, you will receive £325 in total across the three visits. A companion accompanying you on study visits may receive up to £100.

Is it safe?

This is a safety study. Its primary purpose is to assess whether the device is safe and well tolerated.

  • Led by an experienced consultant neurologist
  • Conducted at a specialist centre (National Hospital for Neurology and Neurosurgery)
  • Reviewed and approved by an NHS Research Ethics Committee (ref: 26/WS/0096)

Find out more

Contact the research team: Dr Anna Latorre — a.latorre@ucl.ac.uk020 3448 8066

We will provide you with additional details about study participation in the form of a Participant Information Sheet before any decision is required. Taking part is voluntary, and your decision will not affect your usual care.

The study information above is reproduced from MER-PIS-004 v1.1 (9 July 2026), as approved.