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

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special light treatment on people with Down syndrome to see if it can improve their brain function and cognitive skills like language, attention, and memory.

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.

Is near-infrared light therapy safe for humans?

Research on near-infrared light therapy, also known as transcranial photobiomodulation, shows it is generally safe in humans, with no serious side effects reported in studies for various brain disorders. Some mild side effects like insomnia, headache, and warmth at the treatment site have been noted, but they did not require changes in treatment. ^{1 2 3 4 5}

How does Near-Infrared Transcranial Photobiomodulation treatment differ from other treatments for Down syndrome?

Near-Infrared Transcranial Photobiomodulation is unique because it uses light therapy to potentially improve brain function, which is different from traditional drug or cell-based therapies. This treatment is non-invasive and focuses on stimulating brain activity through light, offering a novel approach compared to existing options that often involve medication or surgical interventions. ^{6 7 8 9 10}

What data supports the effectiveness of Near-Infrared Transcranial Photobiomodulation treatment for Down Syndrome?

While there is no direct evidence for Near-Infrared Transcranial Photobiomodulation in Down Syndrome, research shows that interventions like physical and cognitive training can improve brain connectivity and cognitive performance in individuals with Down Syndrome, suggesting potential for treatments that enhance brain function. ^{7 11 12 13 14}

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. Switzerland pubmed.ncbi.nlm.nih.gov

Building an adaptive brain across development: targets for neurorehabilitation must begin in infancy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Computerized physical and cognitive training improves the functional architecture of the brain in adults with Down syndrome: A network science EEG study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pitfalls and hopes in Down syndrome therapeutic approaches: in the search for evidence-based treatments. [2006]

4. England pubmed.ncbi.nlm.nih.gov

New approaches to studying early brain development in Down syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging of cognitive processing in young adults with Down syndrome. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Transcranial photobiomodulation prevents anxiety and depression via changing serotonin and nitric oxide levels in brain of depression model mice: A study of three different doses of 810 nm laser. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Dose response of transcranial near infrared light stimulation on brain functional connectivity and cognition in older adults-A randomized comparison. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial photobiomodulation in the management of brain disorders. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiomodulation Attenuated Cognitive Dysfunction and Neuroinflammation in a Prenatal Valproic Acid-Induced Autism Spectrum Disorder Mouse Model. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of neonatal neural progenitor cell implantation on adult neuroanatomy and cognition in the Ts65Dn model of Down syndrome. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Integration-free induced pluripotent stem cells model genetic and neural developmental features of down syndrome etiology. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Modulating cognitive deficits and tau accumulation in a mouse model of aging Down syndrome through neonatal implantation of neural progenitor cells. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Sleep-like behavior and 24-h rhythm disruption in the Tc1 mouse model of Down syndrome. [2022]