Brain Activity Clinical Trial
Official title:
Beneficial Effects of Methylene Blue on Human Cognitive and fMRI Measures
Verified date | April 2017 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18 - 65 years, self declared healthy individuals - English speaker and be able to give consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Research Imaging Institute, The University of Texas Health Science Center at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
United States,
Bruchey AK, Gonzalez-Lima F. Behavioral, Physiological and Biochemical Hormetic Responses to the Autoxidizable Dye Methylene Blue. Am J Pharmacol Toxicol. 2008 Jan 1;3(1):72-79. — View Citation
Gonzalez-Lima F, Bruchey AK. Extinction memory improvement by the metabolic enhancer methylene blue. Learn Mem. 2004 Sep-Oct;11(5):633-40. — View Citation
Lim J, Wu WC, Wang J, Detre JA, Dinges DF, Rao H. Imaging brain fatigue from sustained mental workload: an ASL perfusion study of the time-on-task effect. Neuroimage. 2010 Feb 15;49(4):3426-35. doi: 10.1016/j.neuroimage.2009.11.020. Epub 2009 Nov 24. — View Citation
Riha PD, Bruchey AK, Echevarria DJ, Gonzalez-Lima F. Memory facilitation by methylene blue: dose-dependent effect on behavior and brain oxygen consumption. Eur J Pharmacol. 2005 Mar 28;511(2-3):151-8. — View Citation
Wen Y, Li W, Poteet EC, Xie L, Tan C, Yan LJ, Ju X, Liu R, Qian H, Marvin MA, Goldberg MS, She H, Mao Z, Simpkins JW, Yang SH. Alternative mitochondrial electron transfer as a novel strategy for neuroprotection. J Biol Chem. 2011 May 6;286(18):16504-15. doi: 10.1074/jbc.M110.208447. Epub 2011 Mar 18. — View Citation
Wrubel KM, Riha PD, Maldonado MA, McCollum D, Gonzalez-Lima F. The brain metabolic enhancer methylene blue improves discrimination learning in rats. Pharmacol Biochem Behav. 2007 Apr;86(4):712-7. Epub 2007 Mar 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in reaction time assessed by fMRI measurements and PVT measurements | 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). | 1 hour | |
Primary | Improvement in memory assessed by fMRI measurements and DMS measurements | 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). | 1 hour | |
Secondary | Enhanced fMRI responses to visual-motor task | fMRI will be assessed using standard fMRI analysis tools. | 1-2 hours |
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