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Gentle touch may reveal hidden awareness in unresponsive patients

NCT ID NCT06922123

Diagnosis Sponsor: Anna Estraneo Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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)

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Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are studying how the brain and body react to different types of touch in people with disorders of consciousness. Eight adults with these conditions receive pleasant, neutral, and unpleasant touches on their arms and hands while brain activity is recorded using EEG and fNIRS. The goal is to see whether these responses relate to the person's level of consciousness and could help doctors tell apart minimally conscious patients from those who appear unresponsive.

What this could mean

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

Active substance
Tactile stimulation applied to the skin
What this could lead to
If touch triggers measurable brain and behavioral responses, doctors could gain a simple bedside tool to better tell apart patients who are minimally conscious from those who appear unresponsive.
What could go wrong
The study is very small, with only eight participants, so results may not apply broadly. Brain signals in these patients can be faint or noisy, and responses to touch may not reliably track with consciousness level.

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.

Participants

8 people

The number who actually took part.

Started

Jun 2025

Finished

Oct 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.

Who is studied

All patients with DoC who are consecutively admitted to the participating centers of the study

Ages

18 years and older

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: * Clinical diagnosis of a disorder of consciousness (DoC), as determined by repeated Coma Recovery Scale-Revised (CRS-R) assessments; * Age ≥ 18 years; * Time since acute event ≥ 28 days. * Written informed consent obtained from the legal representative Exclusion Criteria: * Presence of large craniectomy that may interfere with fNIRS signal acquisition; * Unstable clinical conditions (e.g., respiratory insufficiency, fever, status epilepticus); * Fractures, paralysis, lesions, or muscular atrophy that prevent proper tactile stimulation of the specified body areas; * Absence of informed consent from the legal representative.

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Conditions

The condition(s) this trial relates to.

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

  • Fondazione Don Carlo Gnocchi

    Sant'Angelo dei Lombardi, Avellino, 83054, Italy

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