Near-Infrared Light Therapy for Down Syndrome
(TransPhoM-DS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPaolo Cassano, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

Trial Summary

What is the purpose of this trial?

This trial is testing a special light treatment on people with Down syndrome to see if it can improve their brain function and cognitive skills like language, attention, and memory.

Eligibility Criteria

This trial is for adults aged 18-30 with Down syndrome, specifically Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21. It's not suitable for those who can't complete study procedures, have untreated sleep apnea, cancer treatments, dementia, non-primary English speakers, recent medication changes or other interventions.

Inclusion Criteria

I am between 18 and 30 years old.

I have been diagnosed with Down syndrome.

Exclusion Criteria

I have been diagnosed with a seizure disorder.

I have had a migraine with an aura in the last 6 months.

English as a second language

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Treatment Details

Interventions

Near-Infrared Transcranial Photobiomodulation (Device)
Sham Transcranial Photobiomodulation (Device)

Trial OverviewThe study tests the effects of transcranial photobiomodulation (tPBM) using near-infrared light on brain activity in individuals with Down syndrome. Participants will be randomly assigned to receive either real tPBM or a sham (placebo) treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)Experimental Treatment1 Intervention

tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.

Group II: Sham Transcranial Photobiomodulation (tPBM-Sham)Placebo Group1 Intervention

tPBM-Sham involves the use of an identical device to tPBM-NIR but does not administer near-infrared light. It mimics the sensation by applying heat but does not actually activate target regions of the brain