What side effects are associated with this type of intervention?

Transcranial photobiomodulation (tPBM) is a treatment that enhances cellular metabolism and promotes neuroprotective effects through the absorption of photons by mitochondrial chromophores. While specific side effects of tPBM in individuals with Down Syndrome are not detailed in the provided context, general side effects of photobiomodulation therapy can include mild headaches, fatigue, and transient dizziness. For broader treatments of Down Syndrome, common side effects depend on the specific intervention but may include gastrointestinal issues from medications, behavioral changes, and potential impacts on growth and development from various therapies.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Down Syndrome that function similarly to Transcranial Photobiomodulation (tPBM). tPBM is a novel approach that enhances cellular metabolism and promotes neuroprotective effects through the absorption of photons by mitochondrial chromophores. Current treatments for Down Syndrome primarily focus on managing symptoms and associated medical conditions rather than targeting the underlying genetic cause. These treatments include therapies for speech, physical, and occupational development, as well as medications for associated conditions such as hypothyroidism and heart defects.

What other types of research exist?

Promising novel alternatives to Transcranial Photobiomodulation for Down Syndrome patients include: 1) Stem cell therapy, which has shown potential in regenerating neural tissues and improving cognitive functions. 2) Pharmacological interventions such as memantine, which is being studied for its neuroprotective effects and potential to improve cognitive function. 3) Cognitive training programs, which utilize computer-based exercises to enhance cognitive abilities and have shown positive results in clinical trials. These alternatives are being actively researched and may offer new avenues for treatment in 2024.

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Device

Near-Infrared Light Therapy for Down Syndrome (TransPhoM-DS Trial)

N/A

Waitlist Available

Led By Paolo Cassano, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Diagnosis of seizure disorder

History of migraine with an aura in the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-treatment (~6 weeks)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but tPBM is generally considered low-risk. Side effects could include discomfort at the application site or headaches. The procedure does not involve drugs and has minimal reported adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 30 years old.

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I have been diagnosed with Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a seizure disorder.

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

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I cannot complete all required study procedures.

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I have sleep apnea that has not been treated.

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I am currently diagnosed with cancer and/or receiving treatment for it.

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I can only speak in one or two-word phrases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-treatment (~6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-treatment (~6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-treatment (~6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cambridge Neuropsychological Test Automated Battery

Change in EEG

Change in Wordless Picture Book

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)Experimental Treatment1 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 Group1 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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Photobiomodulation (tPBM) is a treatment that uses near-infrared light to enhance cellular metabolism and promote neuroprotective effects. This is achieved through the absorption of photons by mitochondrial chromophores, which leads to increased production of adenosine triphosphate (ATP), improved cellular energy, and reduced oxidative stress. For patients with Down Syndrome, these mechanisms are crucial as they can potentially improve cognitive function and overall brain health, addressing some of the neurodevelopmental challenges associated with the condition.

Techniques to Improve Photodynamic Therapy.Light-Emitting Diode Photobiomodulation After Cerebral Ischemia.