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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Down Syndrome

Intervention / Treatment
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* Device: Near-Infrared Transcranial Photobiomodulation
* Device: Sham Transcranial Photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for this study include: adult men and women between the ages of 18 and 30 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 speech/language therapy two weeks prior to baseline testing and throughout study completion changes in medications, augmentative devices and other intervention two weeks prior to baseline testing and throughout study completion untreated obstructive sleep apnea (OSA) contraindications to MRI 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)<br>tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions. | Device: Near-Infrared Transcranial Photobiomodulation<br>* tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.<br>* Other names: tPBM-NIR;|
| Placebo Comparator: Sham Transcranial Photobiomodulation (tPBM-Sham)<br>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 | Device: Sham Transcranial Photobiomodulation<br>* 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<br>* Other names: tPBM-Sham;|

What is the study measuring?
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Primary Outcome Measures

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