Autism Spectrum DisorderNCT06359080
Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL)
A study testing Cognilum TM: Light Treatment Condition in people with Autism Spectrum Disorder, run by JelikaLite LLC at 2 sites in United States.
Trial summary
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Read more about this study
- Who is it for?
- Ages 2 to 7 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?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2022to 11 Dec 2022
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female participants between 2 years and 7 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.
Show all 9Show fewer
- 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.
- Participant previously participated in the JelikaLite pivotal clinical trial that took place in 2021, either in the active or placebo conditions.
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).
- 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
About this study
Official title: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children.
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, 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 10 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
- Keywords
- ASD, Autism, tPBM
- Medical subject headings
- Autism Spectrum Disorder, Autistic 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 10 weeks.
| 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 |
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: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start8 May 2022
- Primary completion11 Dec 2022
- Study completion11 Dec 2022
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 (6)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
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Study This will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the study).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- JelikaLite LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuli Fradkin, MD, Principal investigator, RDT Group NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359080
- Sponsor's protocol ID
- 120200004OL
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2024
- 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 29717196Hamblin 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 27752476Henderson 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 26346298Khuman 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 21851183Leisman 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 29956199Weissman 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
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
- NCT06359080
- Acronym / sponsor ID
- 120200004OL
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Autism, tPBM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- JelikaLite LLCIndustry (pharma, biotech, devices)
- Study start
- 8 May 2022 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, 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 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label Study This will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female participants between 2 years and 7 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 (8 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 10 weeks. | Device | CognilumTM |
Primary outcome
Change in Autism Symptoms
Time frame: 10 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
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.
- 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 9 inclusion and 8 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. 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 6 Jun 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: 10 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 NCT06359080, which also lists 6 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.