Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
- Conditions
- Down Syndrome
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital at the Charlestown Navy Yard
🇺🇸Charlestown, Massachusetts, United States
Massachusetts General Hospital at the Charlestown Navy Yard🇺🇸Charlestown, Massachusetts, United States