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

Not Applicable

Active, not recruiting

• Conditions: Down Syndrome
• Interventions: Device: Near-Infrared Transcranial Photobiomodulation; Device: Sham Transcranial Photobiomodulation

• Registration Number: NCT04668001
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-16
• Study Start: 2021-10-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-07-30
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)	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.
Sham Transcranial Photobiomodulation (tPBM-Sham)	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

Primary Outcome Measures

Name	Time	Method
Change in Cambridge Neuropsychological Test Automated Battery	Baseline to Post-Treatment (~6 weeks)	Reaction Time, Paired Associative Learning, and Motor Screening Task subtests
Change in EEG	Baseline to Post-Treatment (~6 weeks)	Gamma Power (40 Hz) of EEG Signal
Change in Wordless Picture Book	Baseline to Post-Treatment (~6 weeks)	Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language

Trial Locations

Locations (1)

Massachusetts General Hospital at the Charlestown Navy Yard; 🇺🇸 Charlestown, Massachusetts, United States