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Sound waves could unlock the minds of Brain-Injured patients

NCT ID NCT06693492

Knowledge-focused Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether ultrasound can help doctors better understand and treat people with disorders of consciousness, like coma or a minimally conscious state, after severe brain injury. Researchers will use ultrasound to look at brain structure and function, and also try low-intensity focused ultrasound as a treatment. The goal is to find a cheaper, more accessible way to diagnose and help these patients, who are often difficult to assess with standard methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ultrasound (diagnostic and therapeutic)
What this could lead to
If successful, this could lead to a low-cost, bedside tool to better diagnose and treat patients with disorders of consciousness.
What could go wrong
This is an early exploratory study with no phase, so results may not change practice. The treatment effect of ultrasound stimulation is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

May 2023

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Aim 1 Inclusion criteria: * an established diagnosis of DOC (UWS or MCS according to the CRS-R criteria and/or a CRS-R total score ≤22) following severe acquired brain injury; * age\>18 years old; * written informed consent obtained from each patient's representative. Exclusion criteria: * previous psychiatric, neurological, or drug abuse history; * on-going mechanical ventilation. From the population enrolled for aim 1, we plan to select ten patients Inclusion criteria: * 18\<age\<65 years; * medical stability over the previous 30 days; * presence of the following US variables: low brain stiffness, high elasticity, and adequate level of tissue perfusion; * written informed consent obtained from each patient's representative; * structural integrity of both thalami as assessed by MRI. Exclision criteria: * contraindications to MRI examination; * presence of decompressive craniectomy or cranioplasty performed within 30 days; * presence of epileptogenic features on the EEG and/or drug resistant epileptic crisis history; * presence of severe muscoloskeletal impairments which are likely to interfere with the correct positioning required for the intervention.

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Conditions

The condition(s) this trial relates to.

Consciousness Disorders Persistent Vegetative State

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disorders of consciousness

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Neurologico C. Besta, Neurology, Public Helath, Disability Unit

    Milan, Lombardy, 20133, Italy

  • IRCCS Centro Neurolesi Bonino Pulejo, Neuroimaging Lab

    Messina, Sicily, 98124, Italy

  • IRCCS Istituto delle Scienze Neurologiche di Bologna, UO di Medicina Riabilitativa e Neuroriabilitazione

    Bologna, Emilia-Romagna, 40139, Italy

  • Istituto S. Anna, Semi-Intensive Rehabilitation Unit for Acquired Brain Injury

    Crotone, Calabria, 88900, Italy

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