Down SyndromeTransPhoM-DSNCT04668001
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
A study testing Near-Infrared Transcranial Photobiomodulation in people with Down Syndrome, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Near-Infrared Transcranial Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital at the Charlestown Navy Yard
Charlestown, Massachusetts, 02129
About this study
The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down syndrome.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Near-Infrared Transcranial Photobiomodulation, Sham Transcranial Photobiomodulation
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Transcranial PhotobiomodulationDevice
Also called tPBM-NIR
tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
Sham Transcranial PhotobiomodulationDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Near-Infrared Transcranial Photobiomodulation (tPBM-NIR) | Experimental | tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions. Receives: Device: Near-Infrared Transcranial Photobiomodulation |
| Sham Transcranial Photobiomodulation (tPBM-Sham) | Placebo comparator | 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 Receives: Device: Sham Transcranial Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG
Gamma Power (40 Hz) of EEG Signal
Measured: Baseline to Post-Treatment (~6 weeks)
Change in Wordless Picture Book
Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language
Measured: Baseline to Post-Treatment (~6 weeks)
Change in Cambridge Neuropsychological Test Automated Battery
Reaction Time, Paired Associative Learning, and Motor Screening Task subtests
Measured: Baseline to Post-Treatment (~6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start19 Oct 2021
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Cassano, Massachusetts General Hospital
- Investigators
- Paolo Cassano, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668001
- Sponsor's protocol ID
- 2020P003611
- Acronym
- TransPhoM-DS
- Status last verified
- May 2024
- First submitted
- 9 Dec 2020
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT04668001
- Acronym / sponsor ID
- TransPhoM-DS / 2020P003611
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near-Infrared Transcranial Photobiomodulation (tPBM-NIR) | Experimental | Device: Near-Infrared Transcranial PhotobiomodulationtPBM-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) | Placebo comparator | Device: Sham Transcranial PhotobiomodulationtPBM-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 |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- diagnosis of seizure disorder
- diagnosis of dementia
- inability to complete study procedures
- English as a second language
- speech as the secondary mode of communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-Infrared Transcranial PhotobiomodulationAlso: tPBM-NIRtPBM-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) |
| Sham Transcranial PhotobiomodulationAlso: tPBM-ShamtPBM-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) |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Cassano, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-Infrared Transcranial Photobiomodulation in people with Down Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG (time frame: Baseline to Post-Treatment (~6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.