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Can a headband read brain activity in coma patients?

NCT ID NCT07485361

Knowledge-focused Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This observational study tests whether a non-invasive headband called fNIRS can measure brain activity in healthy adults and in people with disorders of consciousness, such as coma, after severe brain injury. Participants wear the headband while receiving gentle touch, listening to sounds, or doing mental tasks. The study does not provide treatment but aims to see if this tool can safely detect brain responses at the bedside, which may help improve future assessments of awareness.

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

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

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

The study population includes two groups: healthy adult volunteers and patients with DoC admitted to the neuro-intensive care unit. Healthy participants will be recruited from the local community and university population to establish baseline fNIRS responses during sensory and cognitive paradigms. Patients with DoC will be recruited from the Neuro-ICU at the participating medical center and include individuals with impaired consciousness following acute brain injury who meet the study eligibility criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Healthy Control Participants: * Age 18 years or older * Proficient in English language * Intact cognition * Montreal Cognitive Assessment (MoCA) score \> 26 DoC Patients: * Age 18 years or older * Proficient in English language * Surrogate decision maker available * Admission to the intensive care unit within 28 days * Documented Glasgow Coma Scale (GCS) score * Auditory Function subscale score ≥1 on the Coma Recovery Scale-Revised (CRS-R) Exclusion Criteria: Healthy Control Participants: * Known baseline hearing impairment without available hearing aids * Neurological or psychiatric history DoC Patients: * Known baseline hearing impairment without available hearing aids * Inability to obtain informed consent * Extensive bilateral frontal injury on available imaging (CT/MRI) * Patients who have undergone craniectomy surgery * IV sedation in the past 24 hours * Absent auditory startle response (\<1 from Auditory Function subscale score of CRS-R)

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic brain injury Coma Consciousness Disorders ocular motor apraxia, Cogan type Persistent Vegetative State traumatic brain injury

As listed by the trial registrant

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

Brain injury COMA Disorders of consciousness Disorders of consciousness due to severe brain injury Minimally conscious state TBI (traumatic brain injury) Unresponsive wakefulness syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCLA School of Nursing; Ronald Reagan Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

More trials for these conditions

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