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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04668001
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Paolo Cassano, Massachusetts General Hospital

Study Description
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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
Down Syndrome Device: Near-Infrared Transcranial Photobiomodulation Device: Sham Transcranial Photobiomodulation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 19, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arms and Interventions
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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 Name: 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 Name: tPBM-Sham


Outcome Measures
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Primary Outcome Measures :
  1. Change in EEG [ Time Frame: Baseline to Post-Treatment (~6 weeks) ]
    Gamma Power (40 Hz) of EEG Signal

  2. Change in Wordless Picture Book/Probes Driven Discussion [ Time Frame: 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 [ Time Frame: Baseline to Post-Treatment (~6 weeks) ]
    Reaction Time, Paired Associative Learning, and Motor Screening Task subtests


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668001


Contacts
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Contact: Paolo Cassano, MD, PhD (617) 643-9622 pcassano@mgh.harvard.edu
Contact: Christopher Funes, MS cjfunes@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital at the Charlestown Navy Yard Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Paolo Cassano, MD, PhD    617-643-9622    pcassano@mgh.harvard.edu   
Contact: Christopher Funes, MS    617-643-2776    cjfunes@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Paolo Cassano, MD, PhD Massachusetts General Hospital
More Information
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Responsible Party: Paolo Cassano, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04668001    
Other Study ID Numbers: 2020P003611
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn