Back to resultsTranscranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome (TransPhoM-DS)
Primary Purpose
Down Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Near-Infrared Transcranial Photobiomodulation
Sham Transcranial Photobiomodulation
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome
Eligibility Criteria
Inclusion criteria for this study include:
- adult men and women between the ages of 18 and 30
- diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)
Exclusion criteria for this study include:
- 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
- speech/language therapy two weeks prior to baseline testing and throughout study completion
- changes in medications, augmentative devices and other intervention two weeks prior to baseline testing and throughout study completion
- untreated obstructive sleep apnea (OSA)
- contraindications to MRI
- 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
Sites / Locations
- Massachusetts General Hospital at the Charlestown Navy YardRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)
Sham Transcranial Photobiomodulation (tPBM-Sham)
Arm Description
tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
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
Outcomes
Primary Outcome Measures
Change in EEG
Gamma Power (40 Hz) of EEG Signal
Change in Wordless Picture Book/Probes Driven Discussion
Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language
Change in Cambridge Neuropsychological Test Automated Battery
Reaction Time, Paired Associative Learning, and Motor Screening Task subtests
Secondary Outcome Measures
Full Information
NCT ID
NCT04668001
First Posted
December 9, 2020
Last Updated
November 8, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04668001
Brief Title
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Acronym
TransPhoM-DS
Official Title
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)
Arm Type
Experimental
Arm Description
tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
Arm Title
Sham Transcranial Photobiomodulation (tPBM-Sham)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Near-Infrared Transcranial Photobiomodulation
Other Intervention Name(s)
tPBM-NIR
Intervention Description
tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Photobiomodulation
Other Intervention Name(s)
tPBM-Sham
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in EEG
Description
Gamma Power (40 Hz) of EEG Signal
Time Frame
Baseline to Post-Treatment (~6 weeks)
Title
Change in Wordless Picture Book/Probes Driven Discussion
Description
Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language
Time Frame
Baseline to Post-Treatment (~6 weeks)
Title
Change in Cambridge Neuropsychological Test Automated Battery
Description
Reaction Time, Paired Associative Learning, and Motor Screening Task subtests
Time Frame
Baseline to Post-Treatment (~6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for this study include:
adult men and women between the ages of 18 and 30
diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)
Exclusion criteria for this study include:
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
speech/language therapy two weeks prior to baseline testing and throughout study completion
changes in medications, augmentative devices and other intervention two weeks prior to baseline testing and throughout study completion
untreated obstructive sleep apnea (OSA)
contraindications to MRI
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Cassano, MD, PhD
Phone
(617) 643-9622
Email
pcassano@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Funes, MS
Email
cjfunes@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Cassano, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital at the Charlestown Navy Yard
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Cassano, MD, PhD
Phone
617-643-9622
Email
pcassano@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christopher Funes, MS
Phone
617-643-2776
Email
cjfunes@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
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