CognitionNCT07209683
The Effect of Near-infrared Light Therapy on Brain Function and Cognition in Young and Older Adults
A study testing transcranial photobiomodulation in people with Cognition and Neurovascular Coupling Mechanism and Cognitive Function, run by University of Oklahoma at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in older adults. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Neurovascular Coupling Mechanism and Cognitive Function, Neurovascular Control
- What is being tested?
- transcranial photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 21-85 years of age
- Adequate hearing and visual acuity to participate in the examinations
- Ability to read and write in English
- Competence to provide informed consent
Who cannot join
- Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
- Cerebrovascular accident other than TIA within 60 days prior to Visit 0
- Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
- Participant currently uses commercial brain stimulation / neuromodulation device or an experimental device as part of a research study, e.g. tDCS, tACS, TBS, DBS, TMS, TPBM, etc.
- Participant currently takes dietary supplements with an expected cerebrovascular benefit, such as NAD- or NR-supplement, L-citrulline, urolithin
- Unstable medical condition, including uncontrolled diabetes, chronic heart issues, heart failure, chronic obstructive pulmonary disease, Stage 2 hypertension uncontrolled by medication (>160/100 mmHg)
- Any other medical condition or medication which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol.
- Pregnancy or trying to become pregnant in the next 1 months (self-reported), breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Campus
Oklahoma City, Oklahoma, 73104
Peter Mukli Mukli, MD PhD, 405-271-8001 ext. 37745, peter-mukli@ou.edu
OUHSC Director, Office of H. R. P. P., 405-271-2045
About this study
Official title: Age-specific Neurovascular Effects of Transcranial Photobiomodulation
The goal of this pilot clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in older adults.
The main questions it aims to answer are:
Read more
- Does tPBM enhance neurovascular coupling responses during memory and finger tapping tasks?
- Are these improvements linked to better cognitive performance and lower levels of brain inflammation and oxidative stress?
Researchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation.
Participants will:
- Receive either active tPBM or sham stimulation sessions for 4 weeks, every other day using a portable intervention device.
- Complete questionnaires and an iPAD-based cognitive testing protocol
- Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), transcranial doppler (TCD) flowmetry.
- Retinal vessel reactivity will be measured during flickering light stimulus using a special camera (dynamic vessel analysis, DVA).
- Provide blood samples to test for biomarkers of inflammation, oxidative stress and brain cell damage.
Read the detailed description
Cognitive decline is a major cause of disability in older adults, and vascular pathologies play a critical role in the genesis of age-related cognitive impairment. Despite advances in understanding the pathophysiology of vascular cognitive impairment (VCI), effective interventions remain scarce. Neurovascular coupling (NVC), the physiological process that adjusts local cerebral blood flow to neuronal activity, is essential for maintaining optimal brain function. According to our preclinical and clinical studies, along with accumulating evidence from other research groups, dysregulation of NVC is increasingly recognized as a key contributor to age-related cognitive decline, highlighting an urgent need for targeted therapeutic strategies.
Transcranial photobiomodulation (tPBM) has emerged as a promising, non-invasive technique with the potential to enhance both neuronal and vascular health. tPBM delivers near-infrared light to cortical areas, stimulating mitochondrial activity, reducing oxidative stress, and improving cerebral hemodynamics. There is increasing evidence that tPBM, which uses red and infrared light with specific wavelengths, confers benefit in various neurological, cardiovascular, and cerebrovascular disorders. However, the underlying neurophysiological changes need to be clarified in human studies, and there are further patient populations who would benefit from a tPBM-based intervention. Optical imaging devices, such as near-infrared spectroscopy (NIRS), offer a means to evaluate tPBM-related changes in brain oxygenation and hemodynamics in an out-of-lab environment, which would significantly improve the feasibility of trials focusing on the effects of tPBM on cerebrovascular health. The practical advantages of tPBM lie in its documented safe application, simplicity of use, affordability, and the potential for home-based interventions.
Recent studies have demonstrated a strong association between cognitive performance and NVC responses in healthy older adults and in patients with mild cognitive impairment. Neuronal activity-induced vasodilation is largely mediated by nitric oxide (NO), whose dissociation from cytochrome c oxidase (CCO) and thus bioavailability is promoted by tPBM. It has also been shown that tPBM confers anti-inflammatory effects in the brain, which is relevant given the heightened inflammatory processes in older adult,s implicating aging-induced neuroinflammation. However, limited clinical evidence exists on the impact of tPBM on NVC, particularly in aging individuals. Moreover, existing research focuses on cognitive benefits rather than neurophysiological or hemodynamic changes, with minimal integration of these outcomes. Addressing this gap, this proposal aims to leverage advanced multimodal neuroimaging techniques to investigate the age-specific tPBM-improvements in NVC and its association with the effects on cognitive function.
Preclinical and early clinical studies suggest that tPBM enhances microvascular perfusion and tissue oxygenation, while simultaneously reducing neuroinflammation and oxidative stress. These dual effects underscore its potential as a multifaceted tool for promoting neural and vascular recovery. To date, evaluations of tPBM in various populations have shown it to be a safe intervention with transient and mild headache as the most common and considerable adverse effect induced by the sessions. Its non-pharmacological nature and compatibility with existing treatments further support its use as an innovative approach for cognitive rehabilitation.
The significance of this project lies in its potential to develop a novel, non-invasive intervention for cognitive impairment in aging populations and also in its ability to elucidate the underlying mechanisms of NVC modulation by tPBM. Findings from this research will provide critical insights into the dual neural and vascular effects of tPBM, laying the groundwork for future combination therapies to address age-related cognitive decline.
- Conditions
- Cognition, Neurovascular Coupling Mechanism and Cognitive Function, Neurovascular Control, Brain Aging, Brain Activity
- Being tested
- transcranial photobiomodulation
- Keywords
- transcranial photobiomodulation, neurovascular coupling, aging, cognitive function, near-infrared spectroscopy, electroencephalography, dynamic vessel analysis, home-based intervention, randomized double-blinded clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial photobiomodulationDevice
Also called near-infrared light therapy
The Vielight Neuro Gamma TPBM devices (©Vielight Inc.) will be used to transmit pulsed near-infrared (NIR) energy through the cranium. Device emits NIR photons at 810 m wavelength generating ~100 mW/cm2 pulsed NIR power modulated at 40 Hz frequency. The six NIR light sources are positioned along the midline over the frontal, pariatel and occipital cortices, bilaterally over the temporal cortex, and intranasally. Due to its portable design, Vielight Neuro TBPM instruments can be used in the laboratory, bedside, or at the participant's home.
Active / sham photobiomodulation sessions last for 20 minutes and will be administered at a laboratory-, home-, or office-based setting depending on the preference of the participant. TPBM will be performed three or four times a week for four weeks, maximum once every other day. Participants will complete a questionnaire of adverse events after each photobiomodulation session.
| Study group | Role | What they receive |
|---|---|---|
| Active near-infrared light therapy | Active comparator | Participants in this arm will receive active transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will be administered. Receives: Device: transcranial photobiomodulation |
| Sham near-infrared light therapy | Sham comparator | Participants in this arm will receive sham transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will not be administered. Receives: Device: transcranial photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Cognitive performance will be assessed by using the following batteries of the NIH Toolbox: 1) Dimensional Change Card Sort [executive function]; 2) Pattern Comparison Processing Speed; 3) List Sorting Working Memory; 4) Flanker Inhibitory Control and Attention; 5) Picture Sequencing Memory and/or 6) Oral Symbol Digit Test.
Measured: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Secondary outcomes (4)
Neurovascular coupling response
Neuronal stimulus-induced cerebral hemodynamic response measured in the brain cortex using functional near-infrared spectroscopy, during a cognitive or motor paradigm. Increase in blood flow velocity recorded from the middle cerebral artery during cognitive n-back paradigm using transcranial Doppler (TCD) flowmetry.
Measured: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Brain wave power
Band limited power in delta-, theta-, alpha-, beta- and gamma-bands during resting and task state measured by electroencephalography (EEG)
Measured: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Functional connectivity
Correlation of simultaneously recorded cerebral hemodynamics (by fNIRS) or phase synchronization of simultaneously recorded cortical potential changes (by EEG).
Measured: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Retinal vasoreactivity
Flickering light induced change in diameter of retinal arterioles and venules assessed by dynamic vessel analysis.
Measured: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Model description
- This is a randomized, parallel-group, double-blind, sham-controlled pilot trial. Healthy adult participants across multiple age groups (21-85 years) will be randomized in a 1:1 ratio to receive either active transcranial photobiomodulation (tPBM) or sham stimulation. Participants in both groups will complete 3-4 sessions per week for 4 weeks (20-minute sessions, every other day). Cognitive and physiological outcomes will be measured at baseline and post-intervention follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209683
- Sponsor's protocol ID
- 18356
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD might not be shared due to the pilot nature of this clinical trial, which will be advertised locally.
Publications
Chao LL. Effects of Home Photobiomodulation Treatments on Cognitive and Behavioral Function, Cerebral Perfusion, and Resting-State Functional Connectivity in Patients with Dementia: A Pilot Trial. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):133-141. doi: 10.1089/photob.2018.4555. Epub 2019 Feb 13.
PubMed 31050950
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-specific Neurovascular Effects of Transcranial Photobiomodulation
- ClinicalTrials.gov ID
- NCT07209683
- Acronym / sponsor ID
- 18356
- Conditions
- Cognition, Neurovascular Coupling Mechanism and Cognitive Function, Neurovascular Control, Brain Aging, Brain Activity
- Keywords
- transcranial photobiomodulation, neurovascular coupling, aging, cognitive function, near-infrared spectroscopy, electroencephalography, dynamic vessel analysis, home-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Oct 2025 (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 goal of this pilot clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in older adults.
The main questions it aims to answer are:
- Does tPBM enhance neurovascular coupling responses during memory and finger tapping tasks?
- Are these improvements linked to better cognitive performance and lower levels of brain inflammation and oxidative stress?
Researchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation.
Participants will:
- Receive either active tPBM or sham stimulation sessions for 4 weeks, every other day using a portable intervention device.
- Complete questionnaires and an iPAD-based cognitive testing protocol
- Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), transcranial doppler (TCD) flowmetry.
- Retinal vessel reactivity will be measured during flickering light stimulus using a special camera (dynamic vessel analysis, DVA).
- Provide blood samples to test for biomarkers of inflammation, oxidative stress and brain cell damage.
Detailed description
Cognitive decline is a major cause of disability in older adults, and vascular pathologies play a critical role in the genesis of age-related cognitive impairment. Despite advances in understanding the pathophysiology of vascular cognitive impairment (VCI), effective interventions remain scarce. Neurovascular coupling (NVC), the physiological process that adjusts local cerebral blood flow to neuronal activity, is essential for maintaining optimal brain function. According to our preclinical and clinical studies, along with accumulating evidence from other research groups, dysregulation of NVC is increasingly recognized as a key contributor to age-related cognitive decline, highlighting an urgent need for targeted therapeutic strategies.
Transcranial photobiomodulation (tPBM) has emerged as a promising, non-invasive technique with the potential to enhance both neuronal and vascular health. tPBM delivers near-infrared light to cortical areas, stimulating mitochondrial activity, reducing oxidative stress, and improving cerebral hemodynamics. There is increasing evidence that tPBM, which uses red and infrared light with specific wavelengths, confers benefit in various neurological, cardiovascular, and cerebrovascular disorders. However, the underlying neurophysiological changes need to be clarified in human studies, and there are further patient populations who would benefit from a tPBM-based intervention. Optical imaging devices, such as near-infrared spectroscopy (NIRS), offer a means to evaluate tPBM-related changes in brain oxygenation and hemodynamics in an out-of-lab environment, which would significantly improve the feasibility of trials focusing on the effects of tPBM on cerebrovascular health. The practical advantages of tPBM lie in its documented safe application, simplicity of use, affordability, and the potential for home-based interventions.
Recent studies have demonstrated a strong association between cognitive performance and NVC responses in healthy older adults and in patients with mild cognitive impairment. Neuronal activity-induced vasodilation is largely mediated by nitric oxide (NO), whose dissociation from cytochrome c oxidase (CCO) and thus bioavailability is promoted by tPBM. It has also been shown that tPBM confers anti-inflammatory effects in the brain, which is relevant given the heightened inflammatory processes in older adult,s implicating aging-induced neuroinflammation. However, limited clinical evidence exists on the impact of tPBM on NVC, particularly in aging individuals. Moreover, existing research focuses on cognitive benefits rather than neurophysiological or hemodynamic changes, with minimal integration of these outcomes. Addressing this gap, this proposal aims to leverage advanced multimodal neuroimaging techniques to investigate the age-specific tPBM-improvements in NVC and its association with the effects on cognitive function.
Preclinical and early clinical studies suggest that tPBM enhances microvascular perfusion and tissue oxygenation, while simultaneously reducing neuroinflammation and oxidative stress. These dual effects underscore its potential as a multifaceted tool for promoting neural and vascular recovery. To date, evaluations of tPBM in various populations have shown it to be a safe intervention with transient and mild headache as the most common and considerable adverse effect induced by the sessions. Its non-pharmacological nature and compatibility with existing treatments further support its use as an innovative approach for cognitive rehabilitation.
The significance of this project lies in its potential to develop a novel, non-invasive intervention for cognitive impairment in aging populations and also in its ability to elucidate the underlying mechanisms of NVC modulation by tPBM. Findings from this research will provide critical insights into the dual neural and vascular effects of tPBM, laying the groundwork for future combination therapies to address age-related cognitive decline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group, double-blind, sham-controlled pilot trial. Healthy adult participants across multiple age groups (21-85 years) will be randomized in a 1:1 ratio to receive either active transcranial photobiomodulation (tPBM) or sham stimulation. Participants in both groups will complete 3-4 sessions per week for 4 weeks (20-minute sessions, every other day). Cognitive and physiological outcomes will be measured at baseline and post-intervention follow-up.
| Arm | Type | Receives |
|---|---|---|
| Active near-infrared light therapy | Active comparator | Device: transcranial photobiomodulationParticipants in this arm will receive active transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will be administered. |
| Sham near-infrared light therapy | Sham comparator | Device: transcranial photobiomodulationParticipants in this arm will receive sham transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will not be administered. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 21-85 years of age
- Adequate hearing and visual acuity to participate in the examinations
- Ability to read and write in English
- Competence to provide informed consent
Key exclusion criteria (8 listed)
- Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
- Cerebrovascular accident other than TIA within 60 days prior to Visit 0
- Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
- Participant currently uses commercial brain stimulation / neuromodulation device or an experimental device as part of a research study, e.g. tDCS, tACS, TBS, DBS, TMS, TPBM, etc.
- Participant currently takes dietary supplements with an expected cerebrovascular benefit, such as NAD- or NR-supplement, L-citrulline, urolithin
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 photobiomodulationAlso: near-infrared light therapyThe Vielight Neuro Gamma TPBM devices (©Vielight Inc.) will be used to transmit pulsed near-infrared (NIR) energy through the cranium. Device emits NIR photons at 810 m wavelength generating ~100 mW/cm2 pulsed NIR power modulated at 40 Hz frequency. The six NIR light sources are positioned along the midline over the frontal, pariatel and occipital cortices, bilaterally over the temporal cortex, and intranasally. Due to its portable design, Vielight Neuro TBPM instruments can be used in the laboratory, bedside, or at the participant's home. Active / sham photobiomodulation sessions last for 20 minutes and will be administered at a laboratory-, home-, or office-based setting depending on the preference of the participant. TPBM will be performed three or four times a week for four weeks, maximum once every other day. Participants will complete a questionnaire of adverse events after each photobiomodulation session. | Device | Active near-infrared light therapy, Sham near-infrared light therapy |
Primary outcome
Cognitive performance
Time frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Cognitive performance will be assessed by using the following batteries of the NIH Toolbox: 1) Dimensional Change Card Sort [executive function]; 2) Pattern Comparison Processing Speed; 3) List Sorting Working Memory; 4) Flanker Inhibitory Control and Attention; 5) Picture Sequencing Memory and/or 6) Oral Symbol Digit Test.
4 secondary outcomes
Neurovascular coupling response
Time frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Brain wave power
Time frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Functional connectivity
Time frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Retinal vasoreactivity
Time frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 31050950Chao LL. Effects of Home Photobiomodulation Treatments on Cognitive and Behavioral Function, Cerebral Perfusion, and Resting-State Functional Connectivity in Patients with Dementia: A Pilot Trial. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):133-141. doi: 10.1089/photob.2018.4555. Epub 2019 Feb 13.
- Individual participant dataSharing planned: No. IPD might not be shared due to the pilot nature of this clinical trial, which will be advertised locally.
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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.
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 in people with Cognition and Neurovascular Coupling Mechanism and Cognitive Function, run by University of Oklahoma 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Mukli, MD, PhD (+1 (405) 271-8001 ext. 37745, peter-mukli@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance (time frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07209683, which also lists 1 linked publication.
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 Feb 2026.