Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome (TransPhoM-DS)

Mass General Brigham

Status: Active, not recruiting

Conditions: Down Syndrome

Treatments: Device: Near-Infrared Transcranial Photobiomodulation; Device: Sham Transcranial Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04668001

2020P003611

Details and patient eligibility

About

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

Full description

This study will compare the effect of tPBM to sham tPBM 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 either tPBM with near-infrared light (tPBM-NIR) or tPBM-Sham and will undergo 18 treatments (3 treatments per week for 6 weeks) in addition to baseline, short-term and long- term follow up visits.

Enrollment: 19 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for this study include:

1. adult men and women between the ages of 16 and 35
2. diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)

Exclusion criteria for this study include:

1. diagnosis of seizure disorder
2. diagnosis of dementia
3. inability to complete study procedures
4. English as a second language
5. speech as the secondary mode of communication
6. speech of less than two-word utterances
7. changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion
8. untreated obstructive sleep apnea (OSA)
9. Participation in other clinical research trials that may influence affect primary outcomes or adherence to the proposed study, as assessed by the PI and the Co-Is
10. candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
11. history of migraine with an aura in the past 6 months
12. current pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)

Experimental group

Description:

tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.

Treatment:

Device: Near-Infrared Transcranial Photobiomodulation

Sham Transcranial Photobiomodulation (tPBM-Sham)

Placebo Comparator group

Description:

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

Treatment:

Device: Sham Transcranial Photobiomodulation