Light therapy headband shows promise for autism in small trial
NCT ID NCT05363982
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device called transcranial photobiomodulation (tPBM), which shines invisible light on the front of the brain through a headband. Researchers wanted to see if it is safe and can improve social and behavioral symptoms in adults with autism. Forty-one adults took part in an 8-week double-blind, placebo-controlled trial at Massachusetts General Hospital.
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 offer a non-invasive, drug-free option to help ease core autism symptoms in adults.
- What could go wrong
- This was a small, early-stage study with only 41 participants. The device may not work better than a placebo, and results may not apply to everyone with autism.
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
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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
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41 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Oct 2024
- 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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18 to 59 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.
Show the full entry requirements Hide 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: * Male or female participants between 18 and 59 years of age (inclusive) * Fulfills Diagnostic and Statistical Manual-5th edition diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview. * Participants with at least moderately severity of ASD symptoms as demonstrated by SRS raw score ≥ 85 and CGI-ASD severity score ≥ 4 * Participants must understand the nature of the study. Participants must be deemed not to have impaired decision-making capacity and must have the capacity to provide direct informed consent. Participants must sign an Institutional Review Board-approved informed consent form before initiation of any study procedures. * Participants must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * Participant experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria. * Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active. * The subject is willing to participate in this study. Exclusion Criteria: * Impaired intellectual capacity (clinically determined). Participants' intellectual capacity will be assessed during the clinical evaluation and determination will be based on intact communicative language, ability to take personal care, history of holding a job and completion of high school (or equivalency credential), and no history of intellectual disability. * Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills) * Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days). * Subjects currently (within past 30 days) experiencing significant symptoms of major psychiatric disorders as clinically determined. * Subjects with an unstable medical condition (that requires clinical attention). * Active suicidal or homicidal ideation, as determined by clinical screening. * The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo). * The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised arteriovenous malformation, implantable shunt - Hakim valve). * Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (verteporfin - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer) * Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment. * Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.
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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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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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