Estimating Brain Biomechanics Using MRI

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01633268
First received: June 30, 2012
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

Background:

- The motion of the brain during normal activity, sports, or a blow to the head is not well understood. Researchers want to study methods to measure how the brain moves during small head movements. This information will be used to build models of how forces act on the brain. The information will help us understand brain injury. Brain movement will be studied through magnetic resonance imaging (MRI) scans.

Objectives:

- To see how the brain shifts in response to small head motions.

Eligibility:

  • Healthy volunteers between 18 and 50 years of age.
  • Participants must be able to move their heads without difficulty.

Design:

  • This study includes a single outpatient visit that lasts about 4 hours. Participants may be asked to return for a second visit.
  • Participants will be screened with a physical exam and medical history. Women who can become pregnant will also have a urine pregnancy test.
  • Participants will have an MRI scan of the brain. The first part of the MRI will take baseline pictures of the brain. The second part of the MRI will involve small head movements. At their own pace, participants will initiate the movement of their head to the left during the scan. The participant will move their head back to the start position at their own pace, and may rest as often as they like.The total scanning session will last no more than 90 minutes.
  • After the scan, participants will complete a questionnaire about using the MRI and performing the head movements.
  • Participants may be asked to return for a second MRI scan. The same head movements will be done at this visit.

Condition
Healthy Volunteer
Traumatic Brain Injury
Brain Mapping
Craniocerebral Trauma
Magnetic Resonance Imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Estimation of Brain Biomechanics Using MRI

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Development of a fast MRI sequence to measure brain motion

Secondary Outcome Measures:
  • Measurements of brain motion in response to head movement

Estimated Enrollment: 55
Study Start Date: June 2012
Detailed Description:

Objective: In this study we will develop and apply imaging techniques to perform the first three-dimensional (3-D) measurements of brain biomechanics during mild head movement in healthy human subjects. Biomechanics is the application of mechanics, or the physical principles in action when force is applied to an object, to the anatomical structure and/or function of organisms. Such techniques will be invaluable for building computational models of brain biomechanics, understanding variability of brain biomechanics across individual characteristics, such as age and sex, and determining brain sub-structures at risk for damage when movement of the head is accelerated, such as during a traumatic event.

Study Population: Measurements will be performed on 55 healthy men and women aged 18-50.

Design: We will build upon the model pioneered by our collaborator, Dr. Philip Bayly. The model places a human subject in a magnetic resonance (MR) scanner with an apparatus that supports the head and allows a specific range of motion. The head support is latched such that it can be released by the subject, which results in a rotation of approximately 30 degrees. Although the support is weighted so that the motion is repeatable if the subject is relaxed, the subject can easily counteract the weight. The resulting acceleration/deceleration is small (in the range of normal activities, such as turning one's head during swimming) and has been validated and used in other human investigations of brain biomechanics. The subject repeats the motion multiple times during the MR scan under their own volition and desired pace to measure motion of the head and brain.

Outcome measures: This project is a pilot study evaluating the potential of extracting three-dimensional estimates of brain deformation, such as strain measurements, using MR imaging. A primary outcome of this project will be a fast MR acquisition sequence for measuring 3-D brain deformation. The sequence will be evaluated by applying the protocol to human subjects, followed by preliminary quantification of the reproducibility and stability of deformation measurements.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Between 18 and 50 years of age
  • Able to provide written informed consent
  • Able to lie flat for up to 2 hours
  • Able to turn head up to 220 times within 45 minutes without discomfort
  • Good general health based on History and Physical (H& P) or History and Assessment (H& A)

EXCLUSION CRITERIA:

  • Contra-indications to MRI scanning without contrast based on RAD& IS department MRI safety questionnaire (see Appendix A)
  • Pregnancy
  • Inner ear problems causing vertigo
  • History of spinal cord injury, head injury or other musculoskeletal condition that may result in an aversion to or difficulty with turning one s head multiple times in succession
  • Claustrophobia (no sedation is permitted under this protocol)
  • Weight more than 250 lbs
  • Height greater than 6'4"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633268

Contacts
Contact: Elizabeth Magrath (301) 451-1869 elizabeth.magrath@nih.gov
Contact: John A Butman, M.D. (301) 402-5827 jbutmana@cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: John A Butman, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01633268     History of Changes
Other Study ID Numbers: 120139, 12-CC-0139
Study First Received: June 30, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
MRI (Magnetic Resonance Imaging)
Traumatic Brain Injury

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014