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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2024-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)

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

Group Type EXPERIMENTAL

Near-Infrared Transcranial Photobiomodulation

Intervention Type DEVICE

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

Sham Transcranial Photobiomodulation (tPBM-Sham)

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

Group Type PLACEBO_COMPARATOR

Sham Transcranial Photobiomodulation

Intervention Type DEVICE

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

Interventions

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Near-Infrared Transcranial Photobiomodulation

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

Intervention Type DEVICE

Sham Transcranial Photobiomodulation

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

Intervention Type DEVICE

Other Intervention Names

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tPBM-NIR tPBM-Sham

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No