Near-Infrared Transcranial Photobiomodulation for Down Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Down SyndromeNear-Infrared Transcranial Photobiomodulation - Device
Eligibility
18 - 30
All Sexes
What conditions do you have?
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Study Summary

This trial will help researchers understand if a transcranial photobiomodulation (tPBM) can improve neural oscillations for people with Down syndrome.

Eligible Conditions
  • Down Syndrome

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Baseline to Post-Treatment (~6 weeks)

Week 6
Change in Cambridge Neuropsychological Test Automated Battery
Change in EEG
Change in Wordless Picture Book/Probes Driven Discussion

Trial Safety

Trial Design

2 Treatment Groups

Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)
1 of 2
Sham Transcranial Photobiomodulation (tPBM-Sham)
1 of 2

Experimental Treatment

Non-Treatment Group

23 Total Participants · 2 Treatment Groups

Primary Treatment: Near-Infrared Transcranial Photobiomodulation · Has Placebo Group · N/A

Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)
Device
Experimental Group · 1 Intervention: Near-Infrared Transcranial Photobiomodulation · Intervention Types: Device
Sham Transcranial Photobiomodulation (tPBM-Sham)
Device
PlaceboComparator Group · 1 Intervention: Sham Transcranial Photobiomodulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to post-treatment (~6 weeks)

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,853,185 Total Patients Enrolled
3 Trials studying Down Syndrome
982 Patients Enrolled for Down Syndrome
Paolo Cassano, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
153 Total Patients Enrolled

Eligibility Criteria

Age 18 - 30 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A doctor diagnoses DS if they believe the person has Trisomy 21, which is a genetic disorder caused by having an extra copy of chromosome 21