Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder

NCT05363982 | Completed Results DMC FDA Device

• 1 other identifier: 2021- P- 002646
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this 8-week double-blind randomized placebo-controlled study is to assess the tolerability, safety, and efficacy of tPBM in adult patients with ASD.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Transcranial Photobiomodulation

Outcome Measures

Primary Outcomes (3)

• Participant Improvement in ASD Symptoms as Assessed by the Clinical Global Impression of Improvement for Autism Spectrum Disorder (CGI-ASD-I)

  The CGI-ASD-I is a clinician-rated measure of ASD symptom improvement since baseline. Improvement scores range from 1 (very much improved) to 7 (very much worse). The outcome reported reflects the number of participants who had CGI-ASD-I scores of 1 or 2 at study endpoint.

  Week 8

• Treatment Responders

  Treatment responders at study endpoint are defined as those who have a Clinical Global Impression of Improvement for ASD (CGI-ASD-I) score ≤2 and a 25% reduction in score from baseline to study endpoint in the Social Responsiveness Scale-Version 2 (SRS-2) total raw score.

  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). The item scores are recoded by a scorer to 0 (not true) to 3 (almost always true) and 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 (11)

• Change From Baseline in Adult Behavior Checklist (ABCL) Total T-score

  Baseline to week 8

• Change From Baseline in Adult ADHD Investigator Symptom Report Scale (AISRS)

  Baseline to week 8

• Change From Baseline in Adult ADHD Self-Report Scale (ASRS)

  Baseline to week 8

• Change From Baseline in Behavior Rating Inventory of Executive Function-Adult Self Report Version (BRIEF-A) Total T-score

  Baseline to week 8

• Improvement in ADHD Symptoms as Assessed by the Clinical Global Impression of Improvement for ADHD (CGI-ADHD-I)

  Week 8

Study Arms (2)

Transcranial Photobiomodulation (tPBM) Treatment

ACTIVE COMPARATOR

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

Device: Transcranial Photobiomodulation (tPBM)

Placebo/ Sham Treatment

SHAM COMPARATOR

The sham treatment will mimic the tPBM procedure, while delivering no light.

Device: Placebo/ Sham

Interventions

Placebo/ Sham DEVICE

The sham treatment will consist of applying all the procedures for the delivery of tPBM, but will not deliver light.

Placebo/ Sham Treatment

Transcranial Photobiomodulation (tPBM) DEVICE

Transcranial Photobiomodulation (tPBM) is a novel treatment approach based on application of an invisible, non-ionizing electromagnetic wave that results in metabolic modulation in tissues targeted. This intervention consists of exposing bilaterally the frontal brain to the electromagnetic wave that penetrates the skin and skull into brain tissue, is non-invasive and minimally dissipated as thermal energy. Other Names: Niraxx G1 Headband

Transcranial Photobiomodulation (tPBM) Treatment

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants between 18 and 59 years of age (inclusive)
• Fulfills Diagnostic and Statistical Manual-5th edition diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview.
• Participants with at least moderately severity of ASD symptoms as demonstrated by SRS raw score ≥ 85 and CGI-ASD severity score ≥ 4
• Participants must understand the nature of the study. Participants must be deemed not to have impaired decision-making capacity and must have the capacity to provide direct informed consent. Participants must sign an Institutional Review Board-approved informed consent form before initiation of any study procedures.
• Participants must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active.
• The subject is willing to participate in this study.

You may not qualify if:

• Impaired intellectual capacity (clinically determined). Participants' intellectual capacity will be assessed during the clinical evaluation and determination will be based on intact communicative language, ability to take personal care, history of holding a job and completion of high school (or equivalency credential), and no history of intellectual disability.
• Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
• Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days).
• Subjects currently (within past 30 days) experiencing significant symptoms of major psychiatric disorders as clinically determined.
• Subjects with an unstable medical condition (that requires clinical attention).
• Active suicidal or homicidal ideation, as determined by clinical screening.
• 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 arteriovenous malformation, implantable shunt - Hakim valve).
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (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 (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.
• Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

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

aceranoglu@mgh.harvard.edu

617-726-7899

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Psychiatrist

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 6, 2022
• Study Start: February 11, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2025-10

Locations

US (1)