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

Down Syndrome Clinical Trial

— TransPhoM-DS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04668001
• Other study ID #: 2020P003611
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: September 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital at the Charlestown Navy Yard	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in EEG	Gamma Power (40 Hz) of EEG Signal	Baseline to Post-Treatment (~6 weeks)
Primary	Change in Wordless Picture Book	Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language	Baseline to Post-Treatment (~6 weeks)
Primary	Change in Cambridge Neuropsychological Test Automated Battery	Reaction Time, Paired Associative Learning, and Motor Screening Task subtests	Baseline to Post-Treatment (~6 weeks)