Status:
ACTIVE_NOT_RECRUITING
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Down Syndrome
Eligibility:
All Genders
16-35 years
Phase:
NA
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. P...
Eligibility Criteria
Inclusion
- Inclusion criteria for this study include:
- adult men and women between the ages of 16 and 35
- diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)
- Exclusion criteria for this study include:
- diagnosis of seizure disorder
- diagnosis of dementia
- inability to complete study procedures
- English as a second language
- speech as the secondary mode of communication
- speech of less than two-word utterances
- changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion
- untreated obstructive sleep apnea (OSA)
- Participation in other clinical research trials that may influence affect primary outcomes or adherence to the proposed study, as assessed by the PI and the Co-Is
- candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
- history of migraine with an aura in the past 6 months
- current pregnancy
Exclusion
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04668001
Start Date
October 19 2021
End Date
September 1 2024
Last Update
May 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital at the Charlestown Navy Yard
Charlestown, Massachusetts, United States, 02129