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Could a light helmet boost brain power in dementia?

NCT ID NCT03750409

Symptom relief Sponsor: Baylor Research Institute 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether wearing a special helmet that shines near-infrared light on the head can help brain cells work better and protect themselves. About 100 people with early to mid-stage dementia will wear the helmet regularly for 8 weeks. Researchers will check memory, thinking, and brain activity before, during, and after treatment to see if there are any improvements.

What this could mean

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

Active substance
near-infrared light helmet (photobiomodulation device)
What this could lead to
If it works, this could point toward a non-drug way to ease memory and thinking problems in early to mid-stage dementia.
What could go wrong
This is a small, early feasibility study with no placebo group, so results may not prove the helmet works. The light may only warm the scalp without affecting the brain.

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 100 people

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

Started

Oct 2018

Expected to finish

Jul 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.

Ages

50 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: * Aged 50-85 years with an independently provided diagnosis of dementia, probable Alzheimer's type. * Dementia symptoms not greater than early to mid-stage dementia * Generally healthy as indicated by recent physical examination within the last 6 months * If labs are available within the last 6 months, renal function, hepatic function, cardiac function should be normal Exclusion Criteria: * Diagnosed actively growing intracranial pathology (tumors etc.) * Misusing illegal substances or alcohol * Previous history of stroke * History of aggression or violence * History of major psychiatric illness * No underlying CNS pathology (confined to tumor, epilepsy only)

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia

As listed by the trial registrant

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

Mild to moderate dementia

Contacts and locations

Locations

  • Baylor Scott and White Medical Center, Temple

    Temple, Texas, 76508, United States

  • Quietmind Foundation

    Elkins Park, Pennsylvania, 19027, United States

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