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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near-Infrared Transcranial Photobiomodulation (tPBM-NIR) | Experimental | tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions. |
|
| Sham Transcranial Photobiomodulation (tPBM-Sham) | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-Infrared Transcranial Photobiomodulation | Device | tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions. |
| 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 | 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) |
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Inclusion criteria for this study include:
Exclusion criteria for this study include:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Cassano, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital at the Charlestown Navy Yard | Charlestown | Massachusetts | 02129 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 7, 2025 | |
| Reset | Aug 22, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 7, 2025 | Aug 22, 2025 |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Sham Transcranial Photobiomodulation | Device | 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 |
|
|
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |