Upstate Medical University’s Golisano Center for Special Needs (GCSN) has launched a study to assess how a novel technology called transcranial photobiomodulation (tPBM) may be used to help children with autism.

Autism spectrum disorder (ASD) is characterized by difficulties with social communication and repetitive behavior patterns that affect the individual’s daily functioning and quality of life. According to the CDC, about 1 in 36 children have been identified with ASD.

Upstate has partnered with JelikaLite Corporation, which developed a non-invasive headband medical device called Cognilum. The headband crosses the wearer’s forehead and falls just over the tops of their ears. Cognilum is specifically designed to deliver tPBM safely and comfortably to autistic children and has been designated by the FDA as a breakthrough device.

Preliminary evidence has shown that this therapy can improve behavioral symptoms of ASD by stimulating targeted brain areas that activate mitochondria, reduce brain inflammation, and improve functional brain connectivity. Independent scientific research, however, is needed to support those claims, said Upstate’s William Sullivan, Ph.D., director of Outpatient Behavioral Services at GCSN. Sullivan is the principal investigator on the clinical trial.

The double-blind, randomized controlled trial will use The Childhood Autism Rating Scale—Second Edition as the primary outcome measure. The Social Responsiveness Scale—Second Edition, Clinical Global Impressions scale, Aberrant Behavior Checklist, Sensory Profile, behavioral observations, and caregiver interviews will be secondary outcome measures.

Forty children are expected to participate in the study, which Sullivan said will be completed in six to eight months. Participants will be fitted with the device and wear it for up to 10 minutes, twice a week, for ten weeks.

 “There are many potential benefits for this type of therapy, including accessibility in the home, ease of implementation for caregivers, and marked improvements in daily functioning,” Sullivan said. “I think our research team here at Upstate is well-suited to conduct a rigorous empirical investigation of this technology, which is very exciting because it has the potential to help a lot of people.”

A $50,000 grant to fund the study was awarded by FuzeHub, a non-profit that supports manufacturers throughout New York State through the Jeff Lawrence Innovation Fund. JelikaLite, based in New York City, approached Upstate for the partnership.

Sullivan is looking for families interested in participating in the study. For more information, email [email protected] or call 315-464-3932.

Caption: William Sullivan, PhD, is leading a clinical trial of a breakthrough of a non-invasive headband that may improve functional brain connectivity.