NCT06352372CompletedPhase 2
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 22 Mar 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Richard Frye
- NCT number
- NCT06352372
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 1 Jul 2024 to the primary completion date, 10 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent treatment with drug that would significantly interact with treatment.
- • Stimulants
- • Anti-Psychotics
- • Antihistamines
Other illness
- Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures
- Genetic syndromes
- 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.
Other
- 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
- Congenital brain malformations
- 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.
Who the study is looking for
- 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.
Age in the registry: 4 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rossignol Medical Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.