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

NCT04668001 | Active Not Recruiting

• 1 other identifier: 2020P003611
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (3)

• Change in EEG

  Gamma Power (40 Hz) of EEG Signal

  Baseline to Post-Treatment (~6 weeks)

• Change in Wordless Picture Book

  Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language

  Baseline to Post-Treatment (~6 weeks)

• Change in Cambridge Neuropsychological Test Automated Battery

  Reaction Time, Paired Associative Learning, and Motor Screening Task subtests

  Baseline to Post-Treatment (~6 weeks)

Study Arms (2)

Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)

EXPERIMENTAL

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

Device: Near-Infrared Transcranial Photobiomodulation

Sham Transcranial Photobiomodulation (tPBM-Sham)

PLACEBO COMPARATOR

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

Device: Sham Transcranial Photobiomodulation

Interventions

Near-Infrared Transcranial Photobiomodulation DEVICE

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

Also known as: tPBM-NIR

Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)

Sham Transcranial Photobiomodulation 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

Also known as: tPBM-Sham

Sham Transcranial Photobiomodulation (tPBM-Sham)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• diagnosis of seizure disorder
• diagnosis of dementia
• 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 at PI's discretion
• untreated obstructive sleep apnea (OSA)
• 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
• candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
• history of migraine with an aura in the past 6 months
• current pregnancy

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital at the Charlestown Navy Yard

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Paolo Cassano, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: October 19, 2021
• Primary Completion: July 30, 2024
• Study Completion: September 1, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)