Estimating Brain Biomechanics Using MRI

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01633268
First received: June 30, 2012
Last updated: April 27, 2016
Last verified: July 2015

June 30, 2012
April 27, 2016
June 2012
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Develop improved MR imaging acquisition protocols for fast imaging of brain motion [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01633268 on ClinicalTrials.gov Archive Site
  • Acquire preliminary data needed for computer simulations of the mechanical response of the brain [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Characterize the stress and strain in specific brain structures during a mild head acceleration [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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Estimating Brain Biomechanics Using MRI
Estimation of Brain Biomechanics Using MRI

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.

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.

Observational
Time Perspective: Prospective
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  • Healthy Volunteer
  • Traumatic Brain Injury
  • Brain Mapping
  • Craniocerebral Trauma
  • Magnetic Resonance Imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
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  • 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"
Both
18 Years to 50 Years
Yes
Contact: Sarah H Yang (301) 451-1869 sarah.yang@nih.gov
Contact: John A Butman, M.D. (301) 402-5827 jbutman@nih.gov
United States
 
NCT01633268
120139, 12-CC-0139
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National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
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Principal Investigator: John A Butman, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP