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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Down Syndrome
• Intervention / Treatment: Device: Near-Infrared Transcranial Photobiomodulation; Device: Sham Transcranial Photobiomodulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital at the Charlestown Navy Yard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: tPBM-NIR
Placebo Comparator: 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	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; Other Names: tPBM-Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EEG	Gamma Power (40 Hz) of EEG Signal	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)
Change in Wordless Picture Book	Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language	Baseline to Post-Treatment (~6 weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Paolo Cassano, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: 2020P003611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No