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Near-Infrared Transcranial Photobiomodulation for Down Syndrome (TransPhoM-DS Trial)

N/A

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

TransPhoM-DS Trial Summary

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

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.Check my eligibility

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.See study design

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.

TransPhoM-DS Trial 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.

TransPhoM-DS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cambridge Neuropsychological Test Automated Battery

Change in EEG

Change in Wordless Picture Book

TransPhoM-DS 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,458 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this experiment?

"Confirmed, the trial is actively recruiting. The clinical study was originally listed on October 19th 2021 and has been modified November 8th 2021 according to data provided by clinicaltrials.gov."

Answered by AI

How many participants are being assessed in this trial?

"Affirmative. The details hosted on clinicaltrials.gov indicates that this research is actively trying to find participants, which was first posted on October 19th 2021 and updated recently on November 8th 2021. For the trial, 23 subjects are being recruited from one site."

Answered by AI

Is the cut-off age for this trial beyond 45 years?

"As outlined in the eligibility requirements, only those aged 18 to 30 are allowed to join this clinical trial."

Answered by AI

Is it feasible for me to become a participant in this clinical research?

"This clinical trial is suitable for individuals who are aged between 18 and 30, have been diagnosed with Down's Syndrome, and seek to be one of the 23 enrolled patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome

Paolo Cassano 2021. "Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04668001.

All > Down Syndrome