Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Estimating Brain Biomechanics Using MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01633268
Recruitment Status : Recruiting
First Posted : July 4, 2012
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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 90 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 one of two head support units that allows a specific range of motion. Each head support is latched such that it can be released by the subject, and results in either a rotation of the head of approximately 30 degrees or a flexion-extension of the head of approximately 4 degrees. Although both supports are 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.


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

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 90 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 one of two head support units that allows a specific range of motion. Each head support is latched such that it can be released by the subject, and results in either a rotation of the head of approximately 30 degrees or a flexion-extension of the head of approximately 4 degrees. Although both supports are 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimation of Brain Biomechanics Using MRI
Actual Study Start Date : July 4, 2012

Group/Cohort
1
Healthy volunteers between age 18 and 50.



Primary Outcome Measures :
  1. technical development of a method for providing threedimensionalmeasurements of brain biomechanics in vivo using MR imaging. [ Time Frame: Day 1 of study ]
    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 deformationmeasurements



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers between age 18 and 50.
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 move 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
  • 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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633268


Contacts
Layout table for location contacts
Contact: Tracy L Cropper, R.N. (301) 402-6132 tcropper@cc.nih.gov
Contact: John A Butman, M.D. (301) 402-5827 jbutman@nih.gov

Locations
Layout table for location information
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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Layout table for investigator information
Principal Investigator: John A Butman, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01633268     History of Changes
Other Study ID Numbers: 120139
12-CC-0139
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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