Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Launched by RICHARD FRYE · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcranial Photobiomodulation (tPBM) for children with Autism Spectrum Disorder (ASD) who have abnormal brain activity. The treatment involves shining a special type of near-infrared light on specific areas of the brain to see if it can help improve focus, eye contact, speech, behavior, and daily skills. The study will include children aged 4 to 12 with moderate to severe autism. To participate, children must have a confirmed diagnosis of autism and be stable on their current treatments for at least two months prior to joining the study.

Participants in this trial will receive the tPBM treatment twice a week for 10 weeks using a wearable device called Cognilum. Throughout the study, doctors will evaluate the children's progress using various assessments and interviews with caregivers. It’s important to note that not all children will qualify; those with severe behavioral issues, certain medical conditions, or who are taking specific medications may be excluded. This trial aims to explore a new, non-invasive approach to help children with autism, and the results could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• 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 \&lt; 5%ile or \&lt;5%ile for weight (male \&lt;11.2kg; female \&lt;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.