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Light helmet shows promise for autism and epilepsy symptoms

NCT ID NCT06352372

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tested a special light helmet (called tPBM) on 6 autistic children aged 4–12 who also had abnormal brain activity or epilepsy. The helmet delivered near-infrared light to specific brain areas twice a week for 10 weeks. The goal was to see if it could safely improve focus, eye contact, speech, behavior, and daily skills. Researchers measured changes using standard autism rating scales and brain wave tests.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Jul 2024

Finished

Feb 2026

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

4 to 12 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: * Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R). * Between 4 and 12 years of age, at baseline. * Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment. * Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period. * Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry * Ability to tolerate procedures, as determined at the discretion of the investigator. * At least one 24hr EEG with data in EDF format that is accessible to investigators. Exclusion Criteria: * Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior * Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill) * Severe prematurity (\<34 weeks gestation) as determined by medical history * Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures * Genetic syndromes * Congenital brain malformations * Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data. * Failure to thrive or Body Mass Index \&lt; 5%ile or \&lt;5%ile for weight (male \&lt;11.2kg; female \&lt;10.8kg by CDC 2000 growth charts) at the time of the study. * Concurrent treatment with drug that would significantly interact with treatment. * • Stimulants * • Anti-Psychotics * • Antihistamines * Excessive Hair that the caregivers are unwilling or unable to shave or braid. * Inability to tolerate the required dosage of tPBM treatment due to sensory issues.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Rossignol Medical Center

    Phoenix, Arizona, 85050, United States

More trials for these conditions

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