Simultaneous FMRI and NIRS to Estimate Brain Cerebral Metabolism

The principal advantages of functional magnetic resonance imaging (fMRI) with blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are: non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied technology to study healthy brain function and pathophysiology associated with disease. In studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals to neurometabolism may be violated. Generally, these effects are ignored, resulting in large study-to-study variability.

Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral metabolism during brain activation during visual stimulation measured with a new fMRI approach that is simple enough for clinical applications will be compared to CMRO2 activation measured using standard qfMRI.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

McLean Imaging Center

Belmont, Massachusetts, 02478, United States

About this study

Healthy subjects will undergo a single imaging session. During the imaging session, fMRI and simultaneous near-infrared spectroscopy measurements will be made during visual stimulation (e.g., viewing a flashing checkerboard). This is a methods development study focused on comparing a new method for estimating CMRO2 associated with brain activation with the standard fMRI approach for estimating CMRO2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male
18 to 40 years old
Physically healthy by self-report

Exclusion criteria

Diagnosis of current drug abuse/dependence, including nicotine, as assessed by DSM-IV criteria

Current diagnosis of Axis I disorder using DSM-IV criteria, or any Axis I disorder within past 5 years
Current daily use of antipsychotic, antidepressant, or other psychoactive prescription drug, as well as daily use of non-prescription drugs
Life threatening or unstable medical illness, or one that can create marked change in mental state
Heavy caffeine use (greater than 300 mg on a regular, daily basis)
History of seizure disorder
Subjects that report any history or current major medical illness (cardiovascular, pulmonary, psychiatric, or neurological disorders)
Subjects who have metal in their body or suffer from claustrophobia cannot participate in this research study.
Additional MR exclusion criteria may include people with:
Cardiac pacemakers
Metal clips on blood vessels (also called stents)
Artificial heart valves
Artificial arms, hands, legs, etc.
Brain stimulator devices
Implanted drug pumps
Ear implants
Eye implants or known metal fragments in eyes
Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
Other metallic surgical hardware in vital areas
Certain tattoos with metallic ink (subjects are asked to inform research staff if they have a tattoo)
Metal Containing Intrauterine Devices (IUDs).
Certain transdermal (skin) patches such as Transderm Scop (scopolamine for motion sickness).

Treatment and study plan

Primary outcomes

Changes in brain activity associated with visual stimulation

Time frame: cross-sectional, start and up to 6 minutes

CMRO2 brain activation in visual cortex associated with visual stimulation

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

Multi-Modal fMRI/NIRS for Estimation of CMRO2 for Neuroimaging Studies of Drug Abuse and Psychiatric Illness Problems

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Apr 5, 2013
Registry last updated: Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed