Could a light cap ease autism symptoms in young children?
NCT ID NCT06359080
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This trial tests whether a device called Cognilum, which shines light on the head (transcranial photobiomodulation), can reduce autism symptoms in children aged 2 to 7 with moderate to severe autism. Children wear the device for up to 15 minutes twice a week for 10 weeks. Researchers measure changes using a standard autism rating scale and brain activity recordings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognilum device (transcranial photobiomodulation)
- What this could lead to
- If it works, this could offer a non-invasive, drug-free way to ease core autism symptoms in young children.
- What could go wrong
- This is a small early-stage trial with only 25 participants, so results may not apply broadly. The treatment is experimental and may not reduce symptoms.
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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25 people
The number who actually took part.
- Started
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May 2022
- Finished
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Dec 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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2 to 7 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: 1. Male or female participants between 2 years and 7 years of age (inclusive), of all races. 2. Previously diagnosed with moderate or severe ASD by a licensed professional. 3. Participants may be receiving any behavioral intervention therapy (e.g., ABA, Floor Time) during the course of the treatment. The final statistical analysis will control for the participants receiving behavioral therapies in control and experimental conditions. We expect the majority of the participants in both control and experimental conditions to be receiving behavioral therapies. There is no known interactions or complications of tPBM with behavioral therapy. 4. Parents of participants must understand the nature of the study. 5. Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures. 6. Parents of 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. 7. Participant child experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria. 8. The participant child is willing to participate in this study. 9. Participant previously participated in the JelikaLite pivotal clinical trial that took place in 2021, either in the active or placebo conditions. Exclusion Criteria: 1. Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days). 2. Participant has been diagnosed with another psychiatric or neurological disorder (e.g. epilepsy) or have exhibited symptoms of major psychiatric disorders within the last 30 days. 3. Participant has an unstable medical condition (that requires clinical attention). 4. Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo). 5. Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve). 6. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (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). 7. Current treatment with a psychotropic medication. 8. Investigator and his/her immediate family, defined as the investigator's child 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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Dr. Steingold Psychology PC
Brooklyn, New York, 11229, United States
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Dr. Steingold Psychology PC
New York, New York, 10019, United States
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