NCT04569058Completed
Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With ADHD
Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With Attention Deficit Hyperactivity Disorder
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 18 Sept 2020
- Start date
- 14 Jan 2021
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Autism
- NCT number
- NCT04569058
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 14 Jan 2021 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve)
- Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment.
Other illness
- 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)
Lab values
- 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
Other
- Impaired intellectual capacity (clinically determined)
- Pregnant or nursing females
- Investigator and his/her immediate family
Who the study is looking for
- 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
Age in the registry: 9 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.