Trial results for a study investigating transcranial photobiomodulation (tPBM) therapy for autistic traits in children and adolescents with ADHD were posted on ClinicalTrials.gov on 2025-12-08. The study, which enrolled 38 participants, reported mean reductions of 8.5 in ADHD-SCL scores and 25.5 in SRS-2 scores.
Background
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity. It frequently co-occurs with Autism Spectrum Disorder (ASD), where individuals may experience challenges in social interaction and communication, alongside restricted, repetitive behaviors. Addressing autistic traits in children and adolescents with ADHD is an important area of research, as these traits can significantly impact daily functioning and quality of life. Transcranial photobiomodulation (tPBM) therapy is an investigational approach being explored for its potential to modulate brain function and improve symptoms in various neurological and psychiatric conditions.
Trial design
This completed open-label study, designated as Phase NA, enrolled 38 children and adolescents with Autism and Attention Deficit Hyperactivity Disorder. The trial assessed the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in youth with ADHD. The intervention involved tPBM treatment, with outcomes measured by changes in symptom checklists and discomfort levels.
Key results
The trial reported several key measurements for the tPBM treatment group:
- Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL): A mean change of -8.5 (Standard Deviation 8.8) in scale score was observed.
- Change From Baseline in Social Responsiveness Scale-2 (SRS-2): A mean change of -25.5 (Standard Deviation 26.4) in scale score was observed.
- Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ):
- 27 participants.
- 4 participants.
- 0 participants.
- 0 participants.
- 0 participants.
What this means
The results from this open-label study suggest that transcranial photobiomodulation (tPBM) therapy may reduce symptoms associated with ADHD and autistic traits in children and adolescents. The observed mean reductions in both ADHD-SCL and SRS-2 scores indicate a potential therapeutic effect. Additionally, the trial collected data on participant discomfort, providing initial insights into the tolerability of tPBM in this population. As an open-label trial, these findings warrant further investigation in larger, controlled studies to confirm efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04569058, titled "Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With ADHD", were posted on 2025-12-08 on clinicaltrials.gov.