Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change in Cambridge Neuropsychological Test Automated Battery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for this study include:
- •adult men and women between the ages of 16 and 35
- •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
- •changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion
- •untreated obstructive sleep apnea (OSA)
- •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
- •candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
- •history of migraine with an aura in the past 6 months
- •current pregnancy
Arms & Interventions
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.
Intervention: Near-Infrared Transcranial Photobiomodulation (Device)
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
Intervention: Sham Transcranial Photobiomodulation (Device)
Outcomes
Primary Outcomes
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
Change in EEG
Time Frame: Baseline to Post-Treatment (~6 weeks)
Gamma Power (40 Hz) of EEG Signal
Change in Wordless Picture Book
Time Frame: Baseline to Post-Treatment (~6 weeks)
Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language
Secondary Outcomes
No secondary outcomes reported
Investigators
Paolo Cassano
Principal Investigator
Massachusetts General Hospital