N/A
N=38
Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With ADHD
Autism · Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04569058 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL) — -8.5 change in scale score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Photobiomodulation (Device)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL) |
-8.5 | — |
| PRIMARY Change From Baseline in Social Responsiveness Scale-2 (SRS-2) |
-25.5 | — |
| SECONDARY Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ) |
27; 4; 0; 0; 0 | — |
Summary
An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth.
Eligibility Criteria
Inclusion Criteria
- Male or female participants between 9 and 17 years of age (inclusive)
- Participant fulfills Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for Attention Deficit Hyperactivity Disorder as established by the clinical diagnostic interview.
- Participants with at least moderate severity of Autism Spectrum Disorder symptoms as demonstrated by Social Responsiveness Scale raw score ≥ 75 or Clinician Global Impression-Autistic Traits severity score ≥ 4
- Participants must understand the nature of the study. Participants must sign an Institutional Review Board-approved informed consent form before initiation of any study procedures.
- Participants are willing and able to cooperate with all tests, examinations and demonstrate ability to appropriately administer the study treatment required by the protocol.
- Participants must have access to a computer with camera and broadband internet connection
Exclusion Criteria
- Impaired intellectual capacity (clinically determined)
- Serious chronic medical or psychiatric condition that, in the investigator's opinion, puts the subject at risk
- The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo)
- The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve)
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment including: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid; and (ALA)- for non-melanoma skin cancer
- Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment.
- Pregnant or nursing females
- Investigator and his/her immediate family
Data sourced from ClinicalTrials.gov (NCT04569058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.