Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder

Completed · Not applicable · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT05363982

Run by

Massachusetts General Hospital

People needed

41

Starts

2022-02-11

Expected to finish

2024-10-31

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

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.
• Participant experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria.
• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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