Note: This study is currently only recruiting patients in the hospital.

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Neuroimaging and EEG Research Study of Light Therapy in Down Syndrome

The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down syndrome.

Massachusetts General Hospital Down Syndrome
10 weeks
Estimated Time Commitment
Any Sex/Gender, 16-35 years
May Be Eligible
Payment up to $1,245
May Be Offered
Survey, MRI scan, Office visit
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

This study will compare the effect of tPBM to sham on gamma neural oscillations in the brain as assessed by EEG, and on language, attention and memory as assessed by neuropsychological testing. Participants will be randomized to receive either active near-infrared light or sham treatment. Participants will undergo 18 treatments (3 treatments per week for 6 weeks) in addition to baseline, short-term, and long-term follow up visits. 


Why it is important

There is an unmet need for accessible, scalable, and effective treatments for cognitive impairments in Down syndrome. tPBM is a novel neuromodulation technique based on non-retinal expsoure to light at specific wavelenghts that may increase gamma neuronal oscillations in the brain. As such, it presents a new treatment avenue that has a low cost, excellent safety profile, and is easy to administer. tPBM therefore has the potential to become widely accessible as a treatment for cognitive impairments in Down syndrome.


What we hope to accomplish

The long-term goal of this project is to develop new effective treatments for improving cognitive impairment in Down syndrome using tPBM.

Principal Investigator

Paolo Cassano

Massachusetts General Hospital

Public Profile

Who can participate


  • Adults between the ages of 16 and 35.

  • Diagnosis of Down syndrome.

  • Language Impairment

Who cannot participate


  • Diagnosis of seizure disorder.

  • Diagnosis of dementia.

  • Migraine with aura within the past 6 months

  • Inability to complete study procedures.

  • English as a second language.

  • Speech as the secondary mode of communication.

  • Speech of less than two-word utterances.

  • Changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion.

  • Untreated obstructive sleep apnea (OSA).

  • Contraindications to MRI (if undergoing optional MRIs)

What you may be asked to do

You will be asked to attend 3 study visits in addition to 18 treatment sessions. During the study visits, you will be asked to complete neuropsychological and EEG testing. During the baseline, short-term, and long-term follow-up visits, you will also undergo an optional MRI scan. The treatment sessions will consist of application of either active or sham tPBM. 


Project activities may include:

  • Survey
  • MRI scan
  • Office visit

Estimated Time Commitment

10 weeks

What You May Get

There may be some improvements in language though it is not guaranteed. The information acquired may help guide the development of future treatments for Down syndrome.

Location

CNY Campus of MGH
149 13th St, Charlestown, MA 02129

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Travel

  • Local travel reimbursed
  • Parking reimbursed
  • Accessible by public transportation

Travel and Parking Details

Participants will be required to attend in-person office visits to the CNY campus of MGH. The building is accessible via public transportation and there is parking garage across the street. You will be provided a parking voucher if you choose to drive and park in the garage. You may also be reimbursed for travel expenses to and from the study visits.

Additional Information

Participating Institutions


Funding Source

  • Foundation
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