NCT04668001

Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down syndrome.

Detailed description

This study will compare the effect of tPBM to sham tPBM on gamma neural oscillations in the brain as assessed by EEG, and on language, attention and memory as assessed by neuropsychological testing. Participants will be randomized to either tPBM with near-infrared light (tPBM-NIR) or tPBM-Sham and will undergo 18 treatments (3 treatments per week for 6 weeks) in addition to baseline, short-term and long- term follow up visits.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DEVICE	Near-Infrared Transcranial Photobiomodulation	tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
DEVICE	Sham Transcranial Photobiomodulation	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

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-07-30
• Completion: 2024-09-01
• First posted: 2020-12-16
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States