Photobiomodulation in Autism Spectrum Disorder (ASD)

Inclusion Criteria:

- Male or female participants between 18 and 59 years of age (inclusive)

- Fulfills DSM-5 diagnostic criteria for autism spectrum disorder as established by the
clinical diagnostic interview.

- Participants with at least moderately severity of Autism Spectrum Disorder (ASD)
symptoms as demonstrated by Social Responsiveness Scale 2 (SRS-2) raw score ≥ 85 and
Clinical Global Impression (CGI-ASD) severity score ≥ 4

- Participants must understand the nature of the study. Participants must sign an IRB-
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.

Exclusion Criteria:

- Impaired intellectual capacity (clinically determined)

- 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 AVM, implantable shunt - Hakim valve).

- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study
enrollment (in US: 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 (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.