Trial results for a study evaluating transcranial photobiomodulation (tPBM) in adult Autism Spectrum Disorder were posted on ClinicalTrials.gov on 2026-01-27, involving 41 participants.
Background
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by persistent challenges in social interaction, communication, and the presence of restricted or repetitive patterns of behavior, interests, or activities. Current management often involves behavioral therapies, educational interventions, and sometimes medication to address co-occurring conditions. Transcranial photobiomodulation (tPBM) is an investigational approach that uses light to stimulate brain cells, with potential therapeutic applications being explored for various neurological and psychiatric conditions. This study aimed to assess the tolerability, safety, and efficacy of tPBM in adult patients with ASD.
Trial design
This completed study, designated as Phase NA, enrolled 41 participants to investigate Autism Spectrum Disorder. The 8-week double-blind randomized placebo-controlled study aimed to assess the tolerability, safety, and efficacy of transcranial photobiomodulation (tPBM) in adult patients with ASD. Participants were randomized to either a tPBM treatment group or a sham control group.
Key results
The trial reported several key measurements related to changes from baseline in various behavioral and symptom scales:
- Change From Baseline in Adult Behavior Checklist (ABCL) Total T-score:
- For the Sham group, the mean change was -4.3 (Standard Deviation 4.1 T-score).
- For the tPBM Treatment group, the mean change was -0.2 (Standard Deviation 8.3 T-score).
- Change From Baseline in Adult ADHD Investigator Symptom Report Scale (AISRS):
- For the Sham group, the mean change was -11.8 (Standard Deviation 8.4 score on a scale).
- For the tPBM Treatment group, the mean change was -8.6 (Standard Deviation 9.6 score on a scale).
- Change From Baseline in Adult ADHD Self-Report Scale (ASRS):
- For the Sham group, the mean change was -13.3 (Standard Deviation 10.2 score on a scale).
- For the tPBM Treatment group, the mean change was -5.1 (Standard Deviation 7.4 score on a scale).
- Change From Baseline in Behavior Rating Inventory of Executive Function-Adult Self Report Version (BRIEF-A) Total T-score:
- For the Sham group, the mean change was -13.0 (Standard Deviation 8.8 T-score).
- For the tPBM Treatment group, the mean change was -4.8 (Standard Deviation 8.9 T-score).
- Improvement in ADHD Symptoms as Assessed by the Clinical Global Impression of Improvement for ADHD (CGI-ADHD-I):
- In the Sham group, 5 Patients showed improvement.
- In the tPBM Treatment group, 6 Patients showed improvement.
- Participant Improvement in ASD Symptoms as Assessed by the Clinical Global Impression of Improvement for Autism Spectrum Disorder (CGI-ASD-I):
- In the Sham group, 5 Participants showed improvement.
- In the tPBM Treatment group, 5 Participants showed improvement.
What this means
Based on the reported mean changes across several symptom scales, the sham group generally showed greater improvements compared to the tPBM treatment group for measures such as the Adult Behavior Checklist (ABCL) Total T-score, Adult ADHD Investigator Symptom Report Scale (AISRS), Adult ADHD Self-Report Scale (ASRS), and Behavior Rating Inventory of Executive Function-Adult Self Report Version (BRIEF-A) Total T-score. For global impression of improvement, the tPBM group had one more patient showing improvement in ADHD symptoms (6 vs 5), while ASD symptom improvement was equal (5 vs 5) between groups. These results suggest that transcranial photobiomodulation, as applied in this study, did not demonstrate a clear therapeutic benefit over sham for adult ASD symptoms or associated ADHD symptoms. The study's relatively small enrollment of 41 participants means these findings should be interpreted with caution, and further research would be needed to fully understand the potential role of tPBM in ASD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05363982, titled "Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder", were posted on 2026-01-27 on clinicaltrials.gov.