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Protocol Details

Physiological and Psychosomatic Effects of Exposure to MRI Scanning Environment

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0057

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 22
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Physiological Measures;
MRI;
Magnetic Resonance Imaging (MRI);
Cognitive Testing

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

- Magnetic resonance imaging (MRI) creates high-quality images of the human body without x-rays. It uses a strong magnetic field and radio waves to take pictures. Researchers want to test a scanner that uses a high magnetic field strength.

Objective:

- To study how the body responds to being in a high field 11.7T MRI scanner.

Eligibility:

- Healthy people ages 22 65.

Design:

- Participants will be screened with a medical history and physical exam. They will complete a healthy volunteer questionnaire and an MRI safety screening form. They may have a 3T MRI scan of the brain.

- Participants will have an MRI scan. They will lie on a table that will slide in and out of the MRI cylinder very slowly. They will be asked to lie still.

- Participants will do simple tasks while inside the machine. These can include listening and responding to questions, tapping fingers, or moving a hand.

- While in the scanner, participants will hear loud knocking noises. They will get earmuffs.

- Right when they exit the scanner, participants will get a questionnaire to fill out. This will ask about how they felt inside the scanner.

- During the MRI, participants heart rate, respiratory rate, and skin temperature will be measured. Before and after the scan, these things plus blood pressure will be measured.

- Participants will be tested before and after being in the MRI scanner. They will answer questions, take pen-and-paper or computer tests, and do simple actions. Their sense of smell may be tested.

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Eligibility

INCLUSION CRITERIA:

-22 - 65 years of age

-In good general health

-Able to understand the procedures and requirements and give informed consent

-Fluent in English

EXCLUSION CRITERIA:

All Subjects will answer the NMR safety screening form and the Healthy volunteer form A subject will be excluded if he/she:

-Has any implanted medical device

-Underwent brain surgery, have a central nervous system illness, a neurological lesion or history of neurological or psychiatric disorders

-Medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, history of sleep apnea

-Diagnosable substance dependence

-Consumes more than 1 alcoholic drink per day for women and up to 2 drinks per day for men on a regular basis

-Has any metal in their body due to by trauma or surgery

-Cannot lie comfortably on their back for up to 60 minutes

-Is pregnant

-Have sustained shrapnel injuries

-Has worked as a machinist, or other occupations that have resulted in metal shavings in their eye

-Has claustrophobia

-Has known hearing problems


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeffrey H. Duyn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D724
10 Center Drive
Bethesda, Maryland 20892
(301) 594-7305
duynjeff@ninds.nih.gov

Susan Fulton Guttman
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D704A
10 Center Drive
Bethesda, Maryland 20892
(301) 451-9912
fultons@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02339883

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