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Could a light cap boost brain power after injury?

NCT ID NCT06956404

Symptom relief Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether shining a special light on the forehead (transcranial photobiomodulation) can improve blood flow and thinking in older adults who had a traumatic brain injury 1-2 years ago. Seventy people aged 55-85 will receive either real or sham light therapy for about 12 minutes a day, three times a week, for six weeks. Researchers will measure changes in brain blood flow using MRI and test thinking skills like memory and attention.

What this could mean

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

Active substance
transcranial photobiomodulation (tPBM) device
What this could lead to
If it works, this could point toward a non-invasive way to improve thinking and brain blood flow in older adults after a traumatic brain injury.
What could go wrong
This is an early-stage study with only 70 people. It tests a device, not a drug, and the benefits may be small or not last long. Side effects are possible but expected to be mild.

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

About 70 people

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

Started

Dec 2025

Expected to finish

Jul 2028

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.

Ages

55 to 85 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: 1. Able to give written informed consent and follow study procedures. 2. Age ≥ 55 years and ≤ 85 years. 3. History of non-penetrating TBI of at least moderate severity, 1. defined by Emergency Department Glasgow Coma Scale (GCS) \< 13, 2. or post-traumatic amnesia \> 24 hours, 3. or loss of consciousness \> 30 minutes, 4. or evidence of trauma-related abnormality on acute neuroimaging. 4. Between 1 and 2 years post injury. Exclusion Criteria: 1. Delayed loss of consciousness due to expanding lesions 2. Diagnosis of dementia, history of brain tumor, or other serious neurological disorder 3. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of alcohol or drug use disorder or history of other major psychiatric illness diagnosed with Mini-International Neuropsychiatric Interview (MINI) 4. History of significant cardiovascular or cerebrovascular pathology before sustaining TBI 5. Unstable medical conditions or medications impacting cognition (e.g., topiramate) 6. Significant skin conditions on the subject's scalp in the area of illumination 7. Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres) 8. Claustrophobia or metallic foreign bodies that would preclude MRI 9. Unwilling/unable to comply with study as judged by the Principal Investigator 10. Body mass index \> 40 kg/m2 to fit comfortably in MRI 11. Past intolerance or hypersensitivity to tPBM 12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

More trials for these conditions

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