Cognitive DeclineNCT06497413
Brain Vascular and Neurocognitive Health
A study testing Transcranial Photobiomodulation and Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered in people with Cognitive Decline and Cognitive Dysfunction, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Dysfunction, Alzheimer Disease
- What is being tested?
- Transcranial Photobiomodulation and Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 17 Sep 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both men and women between the ages of 18-80 and of any race/ethnicity will be included in this study.
Who cannot join
- Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then the investigators may still opt to proceed with data collection.
- Abnormal results from the blood screening will not impact eligibility for the study.
- Individuals with brain injuries/surgeries in a year before the study and individuals who can not provide consent on their own will be excluded from participation.
- Pregnant subjects, women who are breast feeding, and children (i.e. younger than 18) will not be recruited for the study. This will be assessed via self-report.
- If a subject has any allergies to spandex/lycra, the subject will be excluded. However, latex allergies are not contraindicated.
- Individuals with cardiac pacemakers and/or implantable cardioverter defibrillators and individuals with epilepsy will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, 76010
About this study
The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function.
Read the detailed description
Neurocognitive conditions and diseases including cognitive dysfunction, Alzheimer's disease and related dementias (ADRD) are among the fastest growing causes of morbidity and mortality. ADRDs impact > 5 million people in the United States alone and > 47 million people worldwide. The physiological reasons for these conditions are multifactorial but one contributing factor is impaired cerebral vascular function/health. Importantly, impaired cerebral vascular function/health results in cerebral hypoperfusion thereby contributing to neuronal damage and neurodegenerative processes ultimately contributing to the aforementioned neurocognitive impairments. Furthermore, it is critical to investigate therapeutic strategies to combat this elevated risk. One promising approach is Transcranial Photobiomodulation (tPBM) which is a novel and non-invasive strategy that utilizes low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health. However, information regarding the mechanisms and effectiveness of tPBM are still relatively unknown - which represents a critical knowledge gap in the literature.
Therefore, the overall research objective is of this proposal is to determine the impact of tPBM on indices of neurocognitive and cerebral vascular health. The following objectives / aims will be explored:
- Primary Aim - The primary endpoint is the effect of acute (i.e. one-time) and repeated (i.e. up to 8 times in a 4-week period) exposure to tPBM on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include neurocognitive function and indices cerebral blood vessel function/health.
- It is hypothesized that both acute and repeated exposure to tPBM will have a beneficial impact on the outcome variables of neurocognitive function and indices cerebral blood vessel function/health.
- Being tested
- Transcranial Photobiomodulation, Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered
- Keywords
- cerebral oxygenation, cognitive function, brain blood flow
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial PhotobiomodulationDevice
The transcranial photobiomodulation will be delivered through the Neuradiant 1070 Plus-Programmable 4-Quadrant Photobiomodulation System. This is a commercially available helmet that will be purchased from a commercially available source.
Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administeredDevice
In this condition the participants will wear the Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus); however, the light will not be administered.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Photobiomodulation | Experimental | Transcranial Photobiomodulation (tPBM) is a novel and non-invasive strategy that utilizes a helmet that delivers low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health. Receives: Device: Transcranial Photobiomodulation |
| Sham condition | Placebo comparator | In this condition the participants will wear the Transcranial Photobiomodulation (tPBM) headgear; however, no light will be delivered. Receives: Device: Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral vasodilator function
This will be assessed as the increase in blood flow in the middle cerebral artery during a hypercapnic stimulus
Measured: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.
Neurocognitive function
This will be assessed using the NIH Toolbox which is a battery that consists of several cognitive challenges.
Measured: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start16 Apr 2024
- Primary completion31 Aug 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Individuals will be randomly assigned either an experimental or a control condition
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brothers, The University of Texas at Arlington
- Investigators
- Robert M Brothers, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497413
- Sponsor's protocol ID
- 2024-0011
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No There is not a plan to share individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Vascular and Neurocognitive Health
- ClinicalTrials.gov ID
- NCT06497413
- Acronym / sponsor ID
- 2024-0011
- Keywords
- cerebral oxygenation, cognitive function, brain blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 11 Jul 2024 (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 overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function.
Detailed description
Neurocognitive conditions and diseases including cognitive dysfunction, Alzheimer's disease and related dementias (ADRD) are among the fastest growing causes of morbidity and mortality. ADRDs impact > 5 million people in the United States alone and > 47 million people worldwide. The physiological reasons for these conditions are multifactorial but one contributing factor is impaired cerebral vascular function/health. Importantly, impaired cerebral vascular function/health results in cerebral hypoperfusion thereby contributing to neuronal damage and neurodegenerative processes ultimately contributing to the aforementioned neurocognitive impairments. Furthermore, it is critical to investigate therapeutic strategies to combat this elevated risk. One promising approach is Transcranial Photobiomodulation (tPBM) which is a novel and non-invasive strategy that utilizes low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health. However, information regarding the mechanisms and effectiveness of tPBM are still relatively unknown - which represents a critical knowledge gap in the literature.
Therefore, the overall research objective is of this proposal is to determine the impact of tPBM on indices of neurocognitive and cerebral vascular health. The following objectives / aims will be explored:
- Primary Aim - The primary endpoint is the effect of acute (i.e. one-time) and repeated (i.e. up to 8 times in a 4-week period) exposure to tPBM on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include neurocognitive function and indices cerebral blood vessel function/health.
- It is hypothesized that both acute and repeated exposure to tPBM will have a beneficial impact on the outcome variables of neurocognitive function and indices cerebral blood vessel function/health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned either an experimental or a control condition
| Arm | Type | Receives |
|---|---|---|
| Transcranial Photobiomodulation | Experimental | Device: Transcranial PhotobiomodulationTranscranial Photobiomodulation (tPBM) is a novel and non-invasive strategy that utilizes a helmet that delivers low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health. |
| Sham condition | Placebo comparator | Device: Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administeredIn this condition the participants will wear the Transcranial Photobiomodulation (tPBM) headgear; however, no light will be delivered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both men and women between the ages of 18-80 and of any race/ethnicity will be included in this study.
Key exclusion criteria (6 listed)
- Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then the investigators may still opt to proceed with data collection.
- Abnormal results from the blood screening will not impact eligibility for the study.
- Individuals with brain injuries/surgeries in a year before the study and individuals who can not provide consent on their own will be excluded from participation.
- Pregnant subjects, women who are breast feeding, and children (i.e. younger than 18) will not be recruited for the study. This will be assessed via self-report.
- If a subject has any allergies to spandex/lycra, the subject will be excluded. However, latex allergies are not contraindicated.
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 |
|---|---|---|
| Transcranial PhotobiomodulationThe transcranial photobiomodulation will be delivered through the Neuradiant 1070 Plus-Programmable 4-Quadrant Photobiomodulation System. This is a commercially available helmet that will be purchased from a commercially available source. | Device | Transcranial Photobiomodulation |
| Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administeredIn this condition the participants will wear the Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus); however, the light will not be administered. | Device | Sham condition |
Primary outcome
Cerebral vasodilator function
Time frame: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.
This will be assessed as the increase in blood flow in the middle cerebral artery during a hypercapnic stimulus
Neurocognitive function
Time frame: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.
This will be assessed using the NIH Toolbox which is a battery that consists of several cognitive challenges.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No. No There is not a plan to share individual participant data (IPD)
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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.
Robert M Brothers, PhD principal investigator
University of Texas at Arlington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Photobiomodulation and Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered in people with Cognitive Decline and Cognitive Dysfunction, run by The University of Texas at Arlington 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 6 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebral vasodilator function (time frame: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.). The study lists 2 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 6 Oct 2025.