Brain Activity Clinical Trial
Official title:
Beneficial Effects of Methylene Blue on Human Cognitive and fMRI Measures
The purpose of the study is to evaluate whether low-dose USP methylene blue (MB) will: i)
improve short-term memory retention in a delayed match-to-sample task, ii) reduce reaction
time in a psychomotor vigilance test, and iii) enhance responses to a visual-motor task as
measured by functional magnetic resonance imaging (fMRI).
A single low-dose MB or placebo will be orally administered to self-declared healthy adults
using double-blind study design. Non-invasive fMRI data will be acquired before and after MB
administration in the same subjects. Each study will take 2-3 hours, inclusive of an hour
break in between.
Self-declared healthy adult volunteers will be studied using a double-blind,
placebo-controlled design. After informed consent and familiarity with the tasks and the MRI
environment, the subject will enter an MRI scanner and perform the following 3 tasks:
Delayed match-to-sample task: The subject views an object for a few seconds. After a few
(variable) seconds, the subject is presented with two patterns and the subject needs to
press the left or right button based on whether the picture on the left or the right is the
same as the previous picture. The correct and incorrect answers are recorded. A few of these
trials will be cycled, lasting about 5-10 mins.
Psychomotor vigilance test: The subject will receive a visual cue to press a button as fast
as possible. The reaction time is recorded. A false start is when the subject presses before
the visual cue and that trial is not counted. The subject is instructed to avoid a false
start. A few of these trials will be cycled, lasting about 5-10 mins.
Visual-motor task: The subject is instructed to tap his/her 4 fingers against the thumb
every second and cycle through the 4 fingers, in synchrony with an alternating visual
checkerboard patterns. A few of these trials will be cycled, lasting about 5-10 mins.
For calibration of the fMRI signal, fMRI data will also be acquired during a brief (3-5
mins) inhalation of 5% CO2 in air.
fMRI measurements will be made before intervention. The subject comes out of the scanner,
orally ingests the USP MB or placebo, and waits for an hour (break). The same measurements
will then be repeated.
fMRI data acquisition: The MRI pulse sequences include standard and non-invasive anatomical
MRI for co-registration, blood flow and blood-oxygen-level dependent (BOLD) fMRI. fMRI will
image changes in regional brain activity associated with these tasks.
In addition, one week after the fMRI study, the subject will be emailed a short
questionnaire (which takes a few minutes to answer) and the responses can be returned via
email.
Data analysis: Standard fMRI analysis will be analyzed using established fMRI software.
Statistical parametric analysis will be performed to generate activation maps. Task-evoked
changes in brain activities will be analyzed and contrasted between placebo and MB
conditions in the same subjects. Paired t-test will be used for group comparison with P <
0.05 (with bonferroni correction) considered statistically significant.
Expected results: The investigators predict that, compared to placebo, MB will: i) improve
short-term memory retention in a delayed match-to-sample task by memory performance and
enhanced fMRI responses in the prefrontal cortex-hippocampus, ii) reduce reaction time in a
psychomotor vigilance test and enhanced fMRI responses within a cortical sustained attention
network and the motor systems, and iii) enhance responses in the visual and motor cortices.
Power analysis: Sample sizes were calculated for a power of 80%, alpha = 0.05 to detect
statistical difference between MB and placebo. The investigators estimate they will need 40
subjects (complete studies) and thus will recruit 50 subjects to account for potential
failed studies.
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