Physiological and Psychosomatic Effects of Exposure to MRI Scanning Environment
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 22 - 65 |
| Updated: | 1/30/2019 |
| Start Date: | January 15, 2015 |
| End Date: | December 31, 2019 |
| Contact: | Susan Fulton Guttman |
| Email: | fultons@mail.nih.gov |
| Phone: | (301) 451-9912 |
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.
- 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.
Objective
The goals of this pilot study are to establish a normative database of vital signs, cognitive
function and unusual subjective sensations in a 0T scanner. This data will be used as a
reference for a future study of the effects of exposure to a 11.7T static magnetic field.
Study Population
26 healthy volunteers, aged 22-65.
Accrual ceiling =50
Accrual Target =26
Drop outs will be replaced
Design
The study consists of one outpatient screening session and one experimental session. Informed
consent and a history and neurological examination will be carried out at the screening
visit. Vital signs (pulse oximeter, heart rate, respiratory rate and skin temperature) will
be measured immediately before and after the experimental scan session, and pulse oximeter,
heart rate and respiration will be monitored when the subject is in the scanner. Subjects
will remain in the scanner for approximately 1 hour. During the experimental session, while
the subject is in the scanner, they will be asked to carry out a brief test of attention at
10-15 minute intervals, up to 3 times during the session. At the end of the experimental
session, subjects will fill out the MRI exit questionnaire to rate subjective sensations such
as nausea, vertigo, and lightheadedness, on a Likert scale and complete a computerized
neuro-cognitive test battery.
Outcome Measures
The objective of the study is to obtain a normative dataset of neuropsychological test
measures, physiological parameters, and subjective experiences measures in subjects
undergoing 0T exposure.
The goals of this pilot study are to establish a normative database of vital signs, cognitive
function and unusual subjective sensations in a 0T scanner. This data will be used as a
reference for a future study of the effects of exposure to a 11.7T static magnetic field.
Study Population
26 healthy volunteers, aged 22-65.
Accrual ceiling =50
Accrual Target =26
Drop outs will be replaced
Design
The study consists of one outpatient screening session and one experimental session. Informed
consent and a history and neurological examination will be carried out at the screening
visit. Vital signs (pulse oximeter, heart rate, respiratory rate and skin temperature) will
be measured immediately before and after the experimental scan session, and pulse oximeter,
heart rate and respiration will be monitored when the subject is in the scanner. Subjects
will remain in the scanner for approximately 1 hour. During the experimental session, while
the subject is in the scanner, they will be asked to carry out a brief test of attention at
10-15 minute intervals, up to 3 times during the session. At the end of the experimental
session, subjects will fill out the MRI exit questionnaire to rate subjective sensations such
as nausea, vertigo, and lightheadedness, on a Likert scale and complete a computerized
neuro-cognitive test battery.
Outcome Measures
The objective of the study is to obtain a normative dataset of neuropsychological test
measures, physiological parameters, and subjective experiences measures in subjects
undergoing 0T exposure.
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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