Down Syndrome
Conditions
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.
Interventions
DEVICENear-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.
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
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
for this study include: 1. adult men and women between the ages of 16 and 35 2. diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)
Exclusion criteria
for this study include: 1. diagnosis of seizure disorder 2. diagnosis of dementia 3. inability to complete study procedures 4. English as a second language 5. speech as the secondary mode of communication 6. speech of less than two-word utterances 7. changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion 8. untreated obstructive sleep apnea (OSA) 9. 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 10. candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer 11. history of migraine with an aura in the past 6 months 12. current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Cambridge Neuropsychological Test Automated Battery | Baseline to Post-Treatment (~6 weeks) | Reaction Time, Paired Associative Learning, and Motor Screening Task subtests |
Countries
United States
Outcome results
None listed