Autism Spectrum DisorderPhase 2tPBMNCT06352372
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
A Phase 2 study testing noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) in people with Autism Spectrum Disorder and EEG With Periodic Abnormalities, run by Richard Frye at 1 site in United States.
Trial summary
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder, EEG With Periodic Abnormalities, Epilepsy
- What is being tested?
- noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 10 Feb 2026
- Phase
- Phase 2
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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.
- Conditions
- Autism Spectrum Disorder, EEG With Periodic Abnormalities, Epilepsy, Neurodevelopmental Disorders, Neurological Disorder
- Being tested
- noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
- Keywords
- Autism, Epilepsy, Neurological Disorders, Neurodevelopmental disorders, ASD
- Medical subject headings
- Autism Spectrum Disorder, Epilepsy, Neurodevelopmental Disorders, Nervous System Diseases, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)Device
The proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
| Study group | Role | What they receive |
|---|---|---|
| Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child | Experimental | This is a prospective, open level study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) will be the active arm Receives: Device: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scores (CARS)
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
Measured: Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)
Secondary outcomes (1)
EEG Delta Power
Delta power is a measures of the amount of brain activity in the delta frequency as measured by overnight EEG
Measured: Before Treatment and EEG following treatment (within 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jul 2024
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
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 (43)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, open label study including 15 individuals with active seizures and 15 individuals with EEG abnormalities who will receive the same near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Frye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Frye, Rossignol Medical Center
- Investigators
- Richard E Frye, M.D., Ph.D, Principal investigator, Rossignol Medical Center, Phoenix AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352372
- Sponsor's protocol ID
- tPBM Study
- Acronym
- tPBM
- Status last verified
- Sep 2026
- First submitted
- 22 Mar 2024
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barrett DW, Gonzalez-Lima F. Transcranial infrared laser stimulation produces beneficial cognitive and emotional effects in humans. Neuroscience. 2013 Jan 29;230:13-23. doi: 10.1016/j.neuroscience.2012.11.016. Epub 2012 Nov 27.
PubMed 23200785Blanco NJ, Maddox WT, Gonzalez-Lima F. Improving executive function using transcranial infrared laser stimulation. J Neuropsychol. 2017 Mar;11(1):14-25. doi: 10.1111/jnp.12074. Epub 2015 May 28.
PubMed 26017772Cassano P, Petrie SR, Mischoulon D, Cusin C, Katnani H, Yeung A, De Taboada L, Archibald A, Bui E, Baer L, Chang T, Chen J, Pedrelli P, Fisher L, Farabaugh A, Hamblin MR, Alpert JE, Fava M, Iosifescu DV. Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial. Photomed Laser Surg. 2018 Dec;36(12):634-646. doi: 10.1089/pho.2018.4490. Epub 2018 Oct 20.
PubMed 30346890Darlot F, Moro C, El Massri N, Chabrol C, Johnstone DM, Reinhart F, Agay D, Torres N, Bekha D, Auboiroux V, Costecalde T, Peoples CL, Anastascio HD, Shaw VE, Stone J, Mitrofanis J, Benabid AL. Near-infrared light is neuroprotective in a monkey model of Parkinson disease. Ann Neurol. 2016 Jan;79(1):59-75. doi: 10.1002/ana.24542. Epub 2015 Dec 12.
PubMed 26456231Desmet KD, Paz DA, Corry JJ, Eells JT, Wong-Riley MT, Henry MM, Buchmann EV, Connelly MP, Dovi JV, Liang HL, Henshel DS, Yeager RL, Millsap DS, Lim J, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Clinical and experimental applications of NIR-LED photobiomodulation. Photomed Laser Surg. 2006 Apr;24(2):121-8. doi: 10.1089/pho.2006.24.121.
PubMed 16706690De Taboada L, Yu J, El-Amouri S, Gattoni-Celli S, Richieri S, McCarthy T, Streeter J, Kindy MS. Transcranial laser therapy attenuates amyloid-beta peptide neuropathology in amyloid-beta protein precursor transgenic mice. J Alzheimers Dis. 2011;23(3):521-35. doi: 10.3233/JAD-2010-100894.
PubMed 21116053Dmochowski GM, Shereen AD, Berisha D, Dmochowski JP. Near-Infrared Light Increases Functional Connectivity with a Non-thermal Mechanism. Cereb Cortex Commun. 2020 Mar 19;1(1):tgaa004. doi: 10.1093/texcom/tgaa004. eCollection 2020.
PubMed 34296085Giulivi C, Zhang YF, Omanska-Klusek A, Ross-Inta C, Wong S, Hertz-Picciotto I, Tassone F, Pessah IN. Mitochondrial dysfunction in autism. JAMA. 2010 Dec 1;304(21):2389-96. doi: 10.1001/jama.2010.1706.
PubMed 21119085Hipskind SG, Grover FL Jr, Fort TR, Helffenstein D, Burke TJ, Quint SA, Bussiere G, Stone M, Hurtado T. Pulsed Transcranial Red/Near-Infrared Light Therapy Using Light-Emitting Diodes Improves Cerebral Blood Flow and Cognitive Function in Veterans with Chronic Traumatic Brain Injury: A Case Series. Photomed Laser Surg. 2018 Nov 28. doi: 10.1089/pho.2018.4489. Online ahead of print.
PubMed 30418082Karu TI, Pyatibrat LV, Afanasyeva NI. Cellular effects of low power laser therapy can be mediated by nitric oxide. Lasers Surg Med. 2005 Apr;36(4):307-14. doi: 10.1002/lsm.20148.
PubMed 15739174Lampl Y, Zivin JA, Fisher M, Lew R, Welin L, Dahlof B, Borenstein P, Andersson B, Perez J, Caparo C, Ilic S, Oron U. Infrared laser therapy for ischemic stroke: a new treatment strategy: results of the NeuroThera Effectiveness and Safety Trial-1 (NEST-1). Stroke. 2007 Jun;38(6):1843-9. doi: 10.1161/STROKEAHA.106.478230. Epub 2007 Apr 26.
PubMed 17463313Leisman 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 29956199Maiello M, Losiewicz OM, Bui E, Spera V, Hamblin MR, Marques L, Cassano P. Transcranial Photobiomodulation with Near-Infrared Light for Generalized Anxiety Disorder: A Pilot Study. Photobiomodul Photomed Laser Surg. 2019 Oct;37(10):644-650. doi: 10.1089/photob.2019.4677.
PubMed 31647775Naeser MA, Zafonte R, Krengel MH, Martin PI, Frazier J, Hamblin MR, Knight JA, Meehan WP 3rd, Baker EH. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. J Neurotrauma. 2014 Jun 1;31(11):1008-17. doi: 10.1089/neu.2013.3244. Epub 2014 May 8.
PubMed 24568233Naeser MA, Martin PI, Ho MD, Krengel MH, Bogdanova Y, Knight JA, Yee MK, Zafonte R, Frazier J, Hamblin MR, Koo BB. Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. Photomed Laser Surg. 2016 Dec;34(12):610-626. doi: 10.1089/pho.2015.4037.
PubMed 28001756