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| ID | Type | Description | Link |
|---|---|---|---|
| 15-N-0057 |
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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological tests | 2 years | |
| Physiological parameters | 2 years | |
| Subjective experience parameters | 2 years |
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EXCLUSION CRITERIA:
All Subjects will answer the NMR safety screening form and the Healthy volunteer form A subject will be excluded if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey H Duyn, Ph.D. | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
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