Safety and Efficacy of tPBM for Epileptiform Activity in Autism (NCT06352372) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
United States6 participantsStarted 2024-07-01
Plain-language 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. 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Childhood Autism Rating Scores (CARS)
Timeframe: Baseline, Week 11 and Week 15 (One Month Follow-Up)