Autism Spectrum DisorderTPBMASDNCT04660552

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

A study testing Cognilum TM: Light Treatment Condition in people with Autism Spectrum Disorder, run by JelikaLite LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Cognilum TM: Light Treatment Condition
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 2 sitesUnited States
Study dates: 15 Nov 2020to 30 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female participants between 2 years and 6 years of age (inclusive), of all races.
Previously diagnosed with moderate or severe ASD by a licensed professional.
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.
Parents of participants must understand the nature of the study.
Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures.
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.
Participant child experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria.
The participant child is willing to participate in this study.

Who cannot join

Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days).
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.
Participant has an unstable medical condition (that requires clinical attention).
Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo).
Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
Participant has receiving medication on a regular basis for Autism or any other medical condition.

Show all 9Show fewer

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).
Current treatment with a psychotropic medication.
Investigator and his/her immediate family, defined as the investigator's child or grandchild.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Dr. Steingold Psychology PC
Brooklyn, New York, 11229
Dr. Steingold Psychology PC
New York, New York, 10019

Other trials in United States

About this study

The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 8 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.

Read the detailed description

The CognilumTM System is a non-invasive device that uses infrared light (IR), delivered through light emitting diodes (LEDs) built into a head band worn by the patient during treatment.

The proposed clinical investigation is determined by the FDA to be a nonsignificant risk (NSR) device study.

Conditions: Autism Spectrum Disorder
Being tested: Cognilum TM: Light Treatment Condition
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognilum TM: Light Treatment ConditionDevice
The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks.

Study groups in NCT04660552
Study group	Role	What they receive
CognilumTM	Experimental	During the study participants will be wearing the photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (850nm) to specific areas of the child's brain. Receives: Device: Cognilum TM: Light Treatment Condition
Placebo condition	Placebo comparator	During the study participants will be wearing the photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (850nm) will be provided. Receives: Device: Cognilum TM: Light Treatment Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Autism Symptoms
Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition), patients were evaluated after conclusion of the study.
CARS is a validated clinical rating scale that can be used by a trained clinician to rate items indicative of ASD after direct observation of the child.
The scale consists of fifteen items that correspond to the different core domains (e.g., verbal communication, emotional response, and relationships with people) that can be affected by ASD.
Total score (sum of all 15 sub-scales) can range from a low of 15 (no ASD) to a high of 60 (severe ASD).
For the outcome measure we took the difference between the CARS score at the completion of the study and the CARS score at baseline.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202030 Dec 2023

First posted9 Dec 2020
Study start15 Nov 2020
Primary completion31 Dec 2022
Study completion30 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a Randomized, Placebo-controlled, Double Blind, Mixed Design study
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04660552
Sponsor's protocol ID: 19751975
Acronym: TPBMASD
Status last verified: Jun 2026
First submitted: 16 Nov 2020
Last updated: 7 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No individual participant data (IPD) will be available to other researchers

Publications

Bosl WJ, Tager-Flusberg H, Nelson CA. EEG Analytics for Early Detection of Autism Spectrum Disorder: A data-driven approach. Sci Rep. 2018 May 1;8(1):6828. doi: 10.1038/s41598-018-24318-x.
PubMed 29717196
Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
PubMed 27752476
Henderson TA, Morries LD. Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain? Neuropsychiatr Dis Treat. 2015 Aug 21;11:2191-208. doi: 10.2147/NDT.S78182. eCollection 2015.
PubMed 26346298
Khuman J, Zhang J, Park J, Carroll JD, Donahue C, Whalen MJ. Low-level laser light therapy improves cognitive deficits and inhibits microglial activation after controlled cortical impact in mice. J Neurotrauma. 2012 Jan 20;29(2):408-17. doi: 10.1089/neu.2010.1745. Epub 2011 Sep 21.
PubMed 21851183
Leisman G, Machado C, Machado Y, Chinchilla-Acosta M. Effects of Low-Level Laser Therapy in Autism Spectrum Disorder. Adv Exp Med Biol. 2018;1116:111-130. doi: 10.1007/5584_2018_234.
PubMed 29956199
Weissman JR, Kelley RI, Bauman ML, Cohen BH, Murray KF, Mitchell RL, Kern RL, Natowicz MR. Mitochondrial disease in autism spectrum disorder patients: a cohort analysis. PLoS One. 2008;3(11):e3815. doi: 10.1371/journal.pone.0003815. Epub 2008 Nov 26.
PubMed 19043581
Fradkin Y, De Taboada L, Naeser M, Saltmarche A, Snyder W, Steingold E. Transcranial photobiomodulation in children aged 2-6 years: a randomized sham-controlled clinical trial assessing safety, efficacy, and impact on autism spectrum disorder symptoms and brain electrophysiology. Front Neurol. 2024 Apr 26;15:1221193. doi: 10.3389/fneur.2024.1221193. eCollection 2024.
PubMed 38737349
Fradkin Y, Anguera JA, Simon AJ, De Taboada L, Steingold E. Transcranial photobiomodulation for reducing symptoms of autism spectrum disorder and modulating brain electrophysiology in children aged 2-7: an open label study. Front Child Adolesc Psychiatry. 2025 Jan 29;4:1477839. doi: 10.3389/frcha.2025.1477839. eCollection 2025.
PubMed 39944746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children
ClinicalTrials.gov ID: NCT04660552
Acronym / sponsor ID: TPBMASD / 19751975
Conditions: Autism Spectrum Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: JelikaLite LLCIndustry (pharma, biotech, devices)
Study start: 15 Nov 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 9 Dec 2020 (actual)
Results: Posted 16 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The CognilumTM System is a non-invasive device that uses infrared light (IR), delivered through light emitting diodes (LEDs) built into a head band worn by the patient during treatment.

The proposed clinical investigation is determined by the FDA to be a nonsignificant risk (NSR) device study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This is a Randomized, Placebo-controlled, Double Blind, Mixed Design study

Arm	Type	Receives
CognilumTM	Experimental	Device: Cognilum TM: Light Treatment ConditionDuring the study participants will be wearing the photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (850nm) to specific areas of the child's brain.
Placebo condition	Placebo comparator	Device: Cognilum TM: Light Treatment ConditionDuring the study participants will be wearing the photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (850nm) will be provided.

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male or female participants between 2 years and 6 years of age (inclusive), of all races.
Previously diagnosed with moderate or severe ASD by a licensed professional.
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.
Parents of participants must understand the nature of the study.
Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures.

Key exclusion criteria (9 listed)

Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days).
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.
Participant has an unstable medical condition (that requires clinical attention).
Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo).
Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognilum TM: Light Treatment ConditionThe children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks.	Device	CognilumTM, Placebo condition

Primary outcome

Change in Autism Symptoms
Time frame: 8 weeks
Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition), patients were evaluated after conclusion of the study. CARS is a validated clinical rating scale that can be used by a trained clinician to rate items indicative of ASD after direct observation of the child. The scale consists of fifteen items that correspond to the different core domains (e.g., verbal communication, emotional response, and relationships with people) that can be affected by ASD. Total score (sum of all 15 sub-scales) can range from a low of 15 (no ASD) to a high of 60 (severe ASD). For the outcome measure we took the difference between the CARS score at the completion of the study and the CARS score at baseline.

Results and safety

Results posted to the registry on 16 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CognilumTM	19	16
Placebo Condition	15	14

Primary outcome: Change in Autism Symptoms

Time frame: 8 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	CognilumTM n = 16	Placebo Condition n = 14
Value	-9.87 (4.19)	-2.64 (7.99)

CognilumTM vs Placebo Condition: Mean Difference (Net): 7.23 (95% CI 2.357 to 12.107), p = 0.01, t-test, 2 sided

Population analysed: The study enrolled children of both sexes aged two to six years, who had previously been diagnosed with ASD by a licensed professional according to the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM V). Every participant was assessed using Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition). Participants were evaluated before the course of treatment (baseline) and after the course of treatment. Treatment duration was 8 weeks.

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CognilumTM	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Placebo Condition	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29717196Bosl WJ, Tager-Flusberg H, Nelson CA. EEG Analytics for Early Detection of Autism Spectrum Disorder: A data-driven approach. Sci Rep. 2018 May 1;8(1):6828. doi: 10.1038/s41598-018-24318-x.
Background: PubMed 27752476Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
Background: PubMed 26346298Henderson TA, Morries LD. Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain? Neuropsychiatr Dis Treat. 2015 Aug 21;11:2191-208. doi: 10.2147/NDT.S78182. eCollection 2015.
Background: PubMed 21851183Khuman J, Zhang J, Park J, Carroll JD, Donahue C, Whalen MJ. Low-level laser light therapy improves cognitive deficits and inhibits microglial activation after controlled cortical impact in mice. J Neurotrauma. 2012 Jan 20;29(2):408-17. doi: 10.1089/neu.2010.1745. Epub 2011 Sep 21.
Background: PubMed 29956199Leisman G, Machado C, Machado Y, Chinchilla-Acosta M. Effects of Low-Level Laser Therapy in Autism Spectrum Disorder. Adv Exp Med Biol. 2018;1116:111-130. doi: 10.1007/5584_2018_234.
Background: PubMed 19043581Weissman JR, Kelley RI, Bauman ML, Cohen BH, Murray KF, Mitchell RL, Kern RL, Natowicz MR. Mitochondrial disease in autism spectrum disorder patients: a cohort analysis. PLoS One. 2008;3(11):e3815. doi: 10.1371/journal.pone.0003815. Epub 2008 Nov 26.
Results publication: PubMed 38737349Fradkin Y, De Taboada L, Naeser M, Saltmarche A, Snyder W, Steingold E. Transcranial photobiomodulation in children aged 2-6 years: a randomized sham-controlled clinical trial assessing safety, efficacy, and impact on autism spectrum disorder symptoms and brain electrophysiology. Front Neurol. 2024 Apr 26;15:1221193. doi: 10.3389/fneur.2024.1221193. eCollection 2024.
Derived from this study: PubMed 39944746Fradkin Y, Anguera JA, Simon AJ, De Taboada L, Steingold E. Transcranial photobiomodulation for reducing symptoms of autism spectrum disorder and modulating brain electrophysiology in children aged 2-7: an open label study. Front Child Adolesc Psychiatry. 2025 Jan 29;4:1477839. doi: 10.3389/frcha.2025.1477839. eCollection 2025.
Individual participant dataSharing planned: No. No individual participant data (IPD) will be available to other researchers

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuli Fradkin, MD principal investigator

RDT Group NJ

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognilum TM: Light Treatment Condition in people with Autism Spectrum Disorder, run by JelikaLite LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Autism Symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660552, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.