Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01836094
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2013-04-12
Brief Title:
Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Beneficial Effects of Methylene Blue on Human Cognitive and fMRI Measures
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 hisher 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 005 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 005 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
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 hisher 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 005 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None