Health TrialsbyHealthPanel

Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation

ConditionsCognition ImprovementEmotion Regulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFrancisco Gonzalez-Lima, PhD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-85 years old

No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks

Disqualifiers

Transcranial photobiomodulation in the last six weeks

Diabetes

Pregnancy or plans to become pregnant

Breastfeeding or plans to breastfeed

Trial design

Design model

Factorial

Treatments tested in this trial

  • Active transcranial photobiomodulation

    Device

    Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)

  • Active MCT dietary supplementation

    Dietary supplement

    Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation

  • Sham photobiomodulation

    Device

    Identical procedure as active group, but with 5% of light emitted by the device.

  • Sham dietary supplementation

    Dietary supplement

    Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Arm 1: active tPBM, active MCT dietary supplementationActive comparator 2 interventions
Group B: Arm 2: sham tPBM, sham dietary supplementationSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)

Secondary outcomes

1

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)
2

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)
3

Weekly check-in

Open response, verification of compliance of treatment

Time frame
Once per week during treatment
4

Follow-up

Open response of any long-term effects of treatment

Time frame
One month after Visit 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Francisco Gonzalez-Lima, PhD

Lead sponsor

University of Texas at Austin

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: