Beneficial Effects of Methylene Blue on Human Cognitive and fMRI Measures
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvement in reaction time assessed by fMRI measurements and PVT measurements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 65 years, self declared healthy individuals
- •English speaker and be able to give consent
排除标准
- •Contraindication for MRI (pacemaker, metal implants, etc.)
- •Claustrophobia
- •Pregnant (child-bearing age females will be tested to exclude pregnancy onsite)
- •Breast-feeding
- •A history of hypersensitivity or allergy to methylene blue, glucose-6-phosphate dehydrogenase deficiency (determined via questionnaire)
- •Neurological, mental, or cardiovascular disorders
- •Liver, kidney disorders, kidney or liver transplant, hypertension, diabetes, etc.
- •Known hypersensitivity to thiazide diuretics and phenothiazines
- •A history of a psychotic disorder or panic disorder, violent or suicidal behavior, psychiatric institutionalization or imprisonment
- •Any other condition, which in the opinion of the investigator, would put the participant at risk and warrant exclusion from the study
- •Methemoglobinemia
- •On any psychiatric serotonergic antidepressant medication or drugs of abuse currently or within the last 5 weeks
- •History of panic attack
- •Color Blindness
研究组 & 干预措施
Methylene Blue
Methylene Blue, 280mg, oral, one time
干预措施: Methylene Blue (USP grade, 280mg oral) (Drug)
Placebo
FD&C Blue No. 2 (food dye), oral, one time
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in reaction time assessed by fMRI measurements and PVT measurements
时间窗: 1 hour
fMRI will be assessed using standard fMRI analysis tools. Psychomotor-Vigilance-Test (PVT) measurements will be made using a computer program written in Psychology Experiment Building Language (PBL).
Improvement in memory assessed by fMRI measurements and DMS measurements
时间窗: 1 hour
fMRI will be assessed using standard fMRI analysis tools. Delayed-match-to-sample task (DMS) measurements will be made using a computer program written in Psychology Experiment Building Language (PBL).
次要结局
- Enhanced fMRI responses to visual-motor task(1-2 hours)