Physiological and Psychosomatic Effects of Exposure to MRI Scanning Environment

NCT02339883 | Withdrawn

• 2 other identifiers: 15005715-N-0057
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Neuropsychological tests

  2 years

• Physiological parameters

  2 years

• Subjective experience parameters

  2 years

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• In good general health
• Able to understand the procedures and requirements and give informed consent
• Fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Officials

• Jeffrey H Duyn, Ph.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 16, 2015
• Study Start: December 23, 2014
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-09-27