Near-Infrared Light Therapy for Down Syndrome

(TransPhoM-DS Trial)

Overseen By Christopher Funes, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Seizure disorder, Dementia, Untreated OSA, Cancer, others

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how near-infrared light treatment affects brain activity in people with Down syndrome. The treatment uses a device placed on the scalp to stimulate specific brain areas with light. Participants are divided into two groups: one receives the actual light treatment (Near-Infrared Transcranial Photobiomodulation), while the other receives a sham (placebo) treatment that feels similar but does not use the light. This trial may suit individuals aged 16 to 35 with Down syndrome who do not have conditions like seizures or dementia. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on innovative treatments for Down syndrome.

Will I have to stop taking my current medications?

The trial requires that there be no changes in medications two weeks before starting and throughout the study, unless the principal investigator decides otherwise. This means you may need to stay on your current medications without changes.

What prior data suggests that this device is safe for individuals with Down syndrome?

Research has shown that near-infrared transcranial photobiomodulation (tPBM), a type of light therapy, is generally safe and well-tolerated. Studies have found that it does not cause harmful changes in the brain's structure or function. For instance, one study reported no negative effects on cognitive abilities. Another study in rats found no harmful reactions in the brain, such as inflammation or cell damage. Overall, the evidence suggests that tPBM is safe for humans, with no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about near-infrared transcranial photobiomodulation (tPBM-NIR) for Down syndrome because it uses light therapy to directly target and activate specific brain regions. Unlike current treatments, which primarily focus on managing symptoms through medications and behavioral therapies, this approach offers a non-invasive method with the potential to improve cognitive function. By stimulating the brain with near-infrared light, tPBM-NIR could represent a breakthrough in enhancing brain activity, offering a novel pathway to address the underlying neurological aspects of Down syndrome.

What evidence suggests that near-infrared transcranial photobiomodulation is effective for Down syndrome?

Research has shown that using near-infrared light on the brain, known as transcranial photobiomodulation (tPBM), has helped with conditions like autism. In those cases, tPBM improved behavior, social skills, and attention. In this trial, participants will receive either Near-Infrared Transcranial Photobiomodulation (tPBM-NIR) or a Sham Transcranial Photobiomodulation (tPBM-Sham) as a placebo comparator. Although direct evidence for its effects on Down syndrome is not yet available, this treatment activates brain areas that might aid thinking and behavior. Studies also indicate that similar treatments are safe for the brain, suggesting it could be safe to use. ^{1 2 3 6 7}

Who Is on the Research Team?

Paolo Cassano, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-30 with Down syndrome, specifically Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21. It's not suitable for those who can't complete study procedures, have untreated sleep apnea, cancer treatments, dementia, non-primary English speakers, recent medication changes or other interventions.

Inclusion Criteria

I have been diagnosed with Down syndrome.

Exclusion Criteria

I have been diagnosed with a seizure disorder.

I have had a migraine with an aura in the last 6 months.

English as a second language

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) or sham treatment for 6 weeks

6 weeks

18 treatments (3 treatments per week)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Short-term and long-term follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Near-Infrared Transcranial Photobiomodulation
• Sham Transcranial Photobiomodulation

Trial Overview The study tests the effects of transcranial photobiomodulation (tPBM) using near-infrared light on brain activity in individuals with Down syndrome. Participants will be randomly assigned to receive either real tPBM or a sham (placebo) treatment.

How Is the Trial Designed?

Group I: Near-Infrared Transcranial Photobiomodulation (tPBM-NIR) Experimental Treatment 1 Intervention

tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.

Group II: Sham Transcranial Photobiomodulation (tPBM-Sham) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Transcranial photobiomodulation (tPBM) was found to be a safe and feasible treatment for adults with high-functioning autism spectrum disorder (ASD), with 50% of participants showing significant improvement in symptoms after 8 weeks of treatment.

Participants experienced a notable reduction in ASD symptom severity, particularly in areas like social awareness and communication, along with improvements in overall functioning and quality of life, while only mild side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. Ceranoglu, TA., Cassano, P., Hoskova, B., et al.[2022]

Photobiomodulation (PBM) treatment in a mouse model of autism spectrum disorder (ASD) significantly reduced behavioral and histological changes associated with the condition, suggesting its potential as a therapeutic intervention.

PBM treatment also decreased neuroinflammation, as indicated by reduced activation of microglia and astrocytes, which may help counteract the underlying mechanisms of ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Attenuated Cognitive Dysfunction and Neuroinflammation in a Prenatal Valproic Acid-Induced Autism Spectrum Disorder Mouse Model. Kim, UJ., Hong, N., Ahn, JC.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04668001

Transcranial Photobiomodulation With Near-Infrared Light ... The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39009808/

Transcranial photobiomodulation for neurodevelopmental ... t-PBM showed efficacy in improving disruptive behavior, social communication, cognitive rigidity, sleep quality, and attention in ASD; in ...

3. mdpi.com mdpi.com/2304-6732/11/7/670

TransPhoM-DS Study Grant Report: Rationale and ... This study presents the rationale and design of an ongoing randomized, sham-controlled clinical trial aimed at assessing the effectiveness of t-PBM using NIR ...

4. withpower.com withpower.com/trial/phase-down-syndrome-4-2021-ded16

Near-Infrared Light Therapy for Down Syndrome · Info ... What data supports the effectiveness of Near-Infrared Transcranial Photobiomodulation treatment for Down Syndrome? While there is no direct evidence for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497671/

Safety of 810 nm photobiomodulation in the developing brain Safety of 810 nm photobiomodulation in the developing brain: no evidence of glial reactivity or pro-inflammatory cytokine expression in rats.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001955

Transcranial low-level laser stimulation in the near-infrared ... Our data indicate that 1064 nm laser tPBM does not induce adverse effects on brain structure or function, nor does it impair cognitive abilities. tPBM is safe ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04668001?intr=infrared&page=27&rank=261

Transcranial Photobiomodulation With Near-Infrared Light ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...