An interventional study of Active transcranial photobiomodulation and Active MCT dietary supplementation in Cognition Improvement and Emotion Regulation, sponsored by Francisco Gonzalez-Lima, PhD. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Francisco Gonzalez-Lima, PhD · Not applicable, Interventional, and Other
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Among 197 studies in Emotional Regulation with a site in United States — 60 open to participants now, 76 under way, none of them phase 3. Emotional Regulation · United States.
Among the 197 studies in Emotional Regulation with a site in United States, this one is the 40th largest by planned enrollment of the 184 interventional ones that give a count, is one of 18 that started in 2026, is one of 175 with no phase, reaches primary completion later than 70 of the 75 other live ones, and was the 191st registered.
547 studies on the registry are indexed under Emotional Regulation; 190 are open to participants now.
Browse Emotional Regulation studies →60 of the 197 studies in Emotional Regulation with a site in United States are open now. Recruiting first, the newest first:
State University of New York - Upstate Medical University · Sites in United States
Ages 12–29
University of Florida · Sites in United States
Ages 18–24 · Healthy volunteers
University of Florida · Sites in United States
Ages 18–22 · Healthy volunteers
Massachusetts General Hospital · Sites in United States
Ages 22–65
Sam Houston State University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 136 Emotional Regulation studies recruiting now, 36 (26%) set no upper age limit and 96 (71%) stop at 75 or younger; 47 take children under 18; 66 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
197 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 4 1
First in 1988; this study’s year is marked. 18 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 80 across 500 interventional studies indexed under Emotional Regulation.
Median enrollment 74 across the 184 interventional studies, 56 across the 13 observational. Of the 112 that completed or were terminated, 18 (16%) have results posted.
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9 of 197 have an industry lead sponsor. The 10 most frequent:
Francisco Gonzalez-Lima, PhD is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Francisco Gonzalez-Lima, PhD has 1 study filed under Emotional Regulation — fewer than ten, so there is no comparison to draw.
28 of the studies in Emotional Regulation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05414708Walter Reed National Military Medical CenterArt Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms | 2026-12 |
| NCT06019377Portland State UniversityIntervention to Enhance Coping and Help-seeking Among Youth in Foster Care | 2026-12-31 |
| NCT06755827Texas Tech UniversityPilot Testing a Novel Approach to Pediatric Obesity Treatment | 2026-12-31 |
| NCT05651295Matthew Southward, PhDA Precision Medicine Approach to Target Engagement for Emotion Regulation | 2026-12-31 |
| NCT05781100California Polytechnic State University-San Luis ObispoInvestigating Baby Behavior and Family Technology Use Study | 2027-01-01 |
Add all 28 to your calendar (.ics) → With an account.
Among the 197 studies in Emotional Regulation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to investigate the effects of increasing brain energy on cognition. The hypothesis is that by using a special kind of light, in combination with a nutritional supplement, it may be possible to increase energy production in the brain, which may lead to improvements in cognition.
The Gonzalez-Lima Laboratory at the University of Texas at Austin is recruiting participants for a research study. The study examines whether a combined treatment can improve cognitive function. The treatment includes transcranial photobiomodulation (tPBM), a form of light therapy applied to the forehead, along with a dietary supplement. The treatment targets an enzyme called cytochrome-c-oxidase, which plays a key role in how the mitochondria inside brain cells use oxygen to produce energy. As people age, this process often becomes less efficient, contributing to cognitive decline seen in normal aging and in neurodegenerative diseases. The hypothesis is that improving mitochondrial function and cytochrome-c-oxidase activity will boost neuronal energy production and reduce oxidative stress, ultimately enhancing cognitive performance. Previous studies from the Gonzalez-Lima Lab found that applying tPBM to the prefrontal cortex improves brain metabolic activity and enhances cognitive functions such as attention, memory, and executive function. The dietary supplement provides an alternative energy source derived from ketones, which mitochondria can use for oxygen metabolism. This may help bypass the impaired glucose metabolism often seen in aging brains, potentially leading to further cognitive improvements. This study will investigate the cognitive effects of this combined treatment in adults ages 18 to 85. During the first visit to the lab, participants will complete informed consent, health questionnaires, and cognitive assessments, and wear sensors on the head which monitor brain activity. They will also be trained to use a headset device which uses light-emitting diodes (LEDs) to deliver light to the forehead. They will be given daily supplements and instructed on how to maintain a daily log for at-home treatments. Then, for the next two months, participants will complete the daily protocol at home. Weekly check-ins will monitor progress throughout this period. After two months, participants will return to repeat the assessments from the first visit and return their study materials. Participants will receive $200 upon completing the study, and parking expenses will be reimbursed for each visit. Briefly, one aim will be to map the relationship between baseline prefrontal functional connectivity and dimensional performance in cognitive control and affective processing. Another aim will be to evaluate mechanistic efficacy of chronic tPBM in engaging prefrontal circuits and restoring task-based behavioral performance. A final aim is to model the longitudinal relationship between prefrontal circuit health and real-world sleep, circadian stability, and neuroendocrine regulation. By focusing on target-driven biobehavioral mechanisms, this study aims to identify novel therapeutic targets and establish scalable biomarker pipelines.
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Exclusion Criteria:
Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex, and active dietary supplementation with refined coconut oil to provide ketones.
Device: Active transcranial photobiomodulation · Dietary Supplement: Active MCT dietary supplementation
Participants in this arm will undergo the same procedures as the active group, but with sham photobiomodulation (5% of experimental light emitted by the device) and sham dietary supplementation with sunflower oil (comparable caloric value without ketone production).
Device: Sham photobiomodulation · Dietary Supplement: Sham dietary supplementation
Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)
Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation
Identical procedure as active group, but with 5% of light emitted by the device.
Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).
Cognitive assessment: Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a standard questionnaire which was developed to test for cognitive impairment. The MoCA assesses a variety of cognitive functions including executive function, memory, attention, and verbal fluency. Minimum=0; Maximum=30; low score=more impairment.
Time frame: The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Cognitive assessment: Trail-Making Test
The trail-making test (TMT) is a paper-and-pencil "connect-the-dots" task which is used to test visual attention and cognitive flexibility. Completion time (seconds) and number of errors are recorded. Faster time and lower errors=better performance. Maximum time alloted=300 seconds.
Time frame: The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Brain metabolism assessment: Functional Near-Infrared Spectroscopy (fNIRS)
Participants wear a device on the head which assesses brain metabolism non-invasively using functional near-infrared spectroscopy. The device records changes in the concentrations of oxygenated hemoglobin in the prefrontal cortex of the brain.
Time frame: The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Cognitive assessment: 2-Back Task
The 2-back task is a standard computer-based test that assesses attention and short-term memory, in which participants remember a series of letters presented onscreen. Accuracy (number of errors) and speed (reaction time in seconds) are recorded. Faster time and lower errors=better performance. Duration: 5 minutes.
Time frame: The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Cognitive assessment: Delayed Match-to-Sample Task (DMS)
The DMS is a standard computer-based test that assesses visuospatial memory and attention, in which participants remember a grid pattern through a delay and then identify the correct match. Number of correct responses and reaction time in seconds are measured. Faster time and lower errors=better performance. Duration=5 minutes.
Time frame: The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
Weekly check-in
Open response, verification of compliance of treatment
Time frame: Once per week during treatment
Follow-up
Open response of any long-term effects of treatment
Time frame: One month after Visit 2
Plan to share: Yes — What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices). A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (cognitive task data, spectroscopy data).
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: The raw data will be made available by the researchers upon reasonable request by any qualified doctoral researcher (PhD, MD). They will be granted access by contacting the corresponding author/principal investigator (F. Gonzalez-Lima, utcognitivestudy@gmail.com). It will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee (Institutional Review Board) identified for the purpose of individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's shared network drive, but without investigator support other than deposited metadata.
Data sharing details ↗ · labs.la.utexas.edu
Start is estimated for Oct 2026; primary completion for Dec 2029, 38 months later.
Of 391 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 38 months is above that.
Counting every sponsor, half of 397 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Francisco Gonzalez-Lima, PhD