Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With ADHD

NCT04569058 | Completed Results FDA Device

• 1 other identifier: 2020-P-002352
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth.

Conditions

Autism; Attention Deficit Hyperactivity Disorder

Keywords

Autistic Traits; ADHD; Attention; Autism; photobiomodulation; transcranial light therapy

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL)

  The ADHD-SCL is a clinician-rated scale used to determine the number and severity of ADHD symptoms that a patient may be experiencing. It consists of 18 items that rated on a scale from 0 (no symptoms) to 3 (severe symptoms). The item scores are combined into a total score which ranges from 0 to 54, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in ADHD-SCL scores and negative scores represent improvement (i.e., decrease in severity from baseline).

  Baseline to week 8

• Change From Baseline in Social Responsiveness Scale-2 (SRS-2)

  The SRS-2 is a parent-rated scale used to identify the presence and severity of social impairment within the autism spectrum and differentiate it from that which occurs in other disorders. It consists of 65 items that rated on a scale from 1 (not true) to 4 (almost always true). Items are combined into a total score which ranges from 0 to 195, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in SRS Total raw scores and negative scores represent improvement (i.e., decrease in severity from baseline).

  Baseline to week 8

Secondary Outcomes (1)

• Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ)

  Week 8 (study endpoint)

Study Arms (1)

Transcranial Photobiomodulation

EXPERIMENTAL

Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.

Device: Transcranial Photobiomodulation

Interventions

Transcranial Photobiomodulation DEVICE

Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.

Also known as: Niraxx G1 Headband

Transcranial Photobiomodulation

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Autistic Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Results Point of Contact

• Title: T. Atilla Ceranoglu, MD
• Organization: Massachusetts General Hospital

aceranoglu@mgh.harvard.edu

617-726-1291

Study Officials

• T. Atilla Ceranoglu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Psychiatrist

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 29, 2020
• Study Start: January 14, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)