Physiological and Psychosomatic Effects of Exposure to MRI Scanning Environment

Healthy Volunteers Clinical Trial

Official title:

Physiological and Psychosomatic Effects of Exposure to MRI Scanning Environment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02339883
• Other study ID #: 150057
• Secondary ID: 15-N-0057
• Status: Withdrawn
• Start date: December 23, 2014
• Est. completion date: September 27, 2019

Study information

• Verified date: September 27, 2019
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

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

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological tests		2 years
Primary	Physiological parameters		2 years
Primary	Subjective experience parameters		2 years