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Can emotional brain waves wake the unresponsive?

NCT ID NCT06204172

Symptom relief Sponsor: IRCCS Centro Neurolesi Bonino Pulejo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new device called Intensive Neurowave Emotional Stimulation (INES) in 40 people with disorders of consciousness after severe brain injury. The experimental group received multisensory stimulation with emotionally meaningful audio-visual content, while the control group got traditional stimulation. Researchers measured cognitive and motor function improvements over four weeks and at a one-month follow-up.

What this could mean

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

Active substance
Intensive Neurowave Emotional Stimulation (INES) device
What this could lead to
If it works, this could point toward a new rehabilitation method to help people with disorders of consciousness regain cognitive and motor function.
What could go wrong
This is a very small pilot study with only 40 participants, so results may not apply to everyone. The treatment is experimental and may not lead to meaningful improvement.

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

40 people

The number who actually took part.

Started

Dec 2023

Finished

Mar 2025

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

16 to 65 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.

Inclusion Criteria: * Age between 18 and 65 years. * Glasgow Coma Scale (GCS) \> 8. * Level of Cognitive Scale (LCF) = 1-3. * Consent is signed by the legal guardian. Exclusion Criteria: * Age \< 18 years or \> 65 years. * Lack of consent from the legal guardian. * Patients with cranial anatomical alterations hindering proper electrode, headset, etc., placement. * Patients showed no neurophysiological responses in visual evoked potentials (VEP) and no V wave in auditory evoked potentials (AEP).

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Conditions

The condition(s) this trial relates to.

brain injury Consciousness Disorders

As listed by the trial registrant

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

Disorders of consciousness

Contacts and locations

Locations

  • IRCCS Centro Neurolesi Bonino Pulejo

    Messina, Italy/Messina, 98124, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.