Light helmet shows promise for autism and epilepsy symptoms
NCT ID NCT06352372
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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6 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Feb 2026
- Lead sponsor
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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
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4 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 \< 5%ile or \<5%ile for weight (male \<11.2kg; female \<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
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Rossignol Medical Center
Phoenix, Arizona, 85050, United States
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Other studies related to the condition(s) this trial covers.
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