Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04668001
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2020-12-09
Brief Title:
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TransPhoM-DS
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None