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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04668001
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
14.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Near-Infrared Transcranial Photobiomodulation
  • Device: Sham Transcranial Photobiomodulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Actual Study Start Date :
Oct 19, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in EEG [Baseline to Post-Treatment (~6 weeks)]

      Gamma Power (40 Hz) of EEG Signal

    2. Change in Wordless Picture Book/Probes Driven Discussion [Baseline to Post-Treatment (~6 weeks)]

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

    3. Change in Cambridge Neuropsychological Test Automated Battery [Baseline to Post-Treatment (~6 weeks)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria for this study include:

    1. adult men and women between the ages of 18 and 30

    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. speech/language therapy two weeks prior to baseline testing and throughout study completion

    8. changes in medications, augmentative devices and other intervention two weeks prior to baseline testing and throughout study completion

    9. untreated obstructive sleep apnea (OSA)

    10. contraindications to MRI

    11. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital at the Charlestown Navy Yard Charlestown Massachusetts United States 02129

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paolo Cassano, Principal Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04668001
    Other Study ID Numbers:
    • 2020P003611
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Down Syndrome
    Syndrome

    Study Results

    No Results Posted as of Nov 16, 2021