Simultaneous FMRI and NIRS to Estimate Brain Cerebral Metabolism

NCT ID: NCT01825096

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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baseline

No intervention. Participants are scanned at baseline.

No interventions assigned to this group

Eligibility Criteria

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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.
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lisa Nickerson, PhD

Assistant Physicist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa D Nickerson, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Imaging Center

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012p00622

Identifier Type: -

Identifier Source: org_study_id

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