Estimating Brain Biomechanics Using MRI

NCT01633268 | Completed

• 2 other identifiers: 12013912-CC-0139
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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 18-65. 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. ...

Conditions

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

Keywords

MRI (Magnetic Resonance Imaging); Traumatic Brain Injury; Natural History

Outcome Measures

Primary Outcomes (1)

• technical development of a method for providing three-dimensional measurements of brain biomechanics in vivo using MR imaging.

  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

  Day 1 of study

Secondary Outcomes (1)

• Measure of preliminary database of brain deformation

  End of study

Study Arms (1)

Healthy Volunteers

Healthy men and women aged 18-65

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers between age 18 and 65.

You may qualify if:

• Between 18 and 65 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)

You may not qualify if:

• Contra-indications to MRI scanning without contrast based on RADIS 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"
• All employees/staff supervised by the Principle Investigator or Lead Associate Investigator are excluded from participation.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Allen ME, Weir-Jones I, Motiuk DR, Flewin KR, Goring RD, Kobetitch R, Broadhurst A. Acceleration perturbations of daily living. A comparison to 'whiplash'. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1285-90. doi: 10.1097/00007632-199405310-00017.

  PMID: 8073323 BACKGROUND

• Bayly PV, Cohen TS, Leister EP, Ajo D, Leuthardt EC, Genin GM. Deformation of the human brain induced by mild acceleration. J Neurotrauma. 2005 Aug;22(8):845-56. doi: 10.1089/neu.2005.22.845.

  PMID: 16083352 BACKGROUND

• Brun CC, Lepore N, Pennec X, Lee AD, Barysheva M, Madsen SK, Avedissian C, Chou YY, de Zubicaray GI, McMahon KL, Wright MJ, Toga AW, Thompson PM. Mapping the regional influence of genetics on brain structure variability--a tensor-based morphometry study. Neuroimage. 2009 Oct 15;48(1):37-49. doi: 10.1016/j.neuroimage.2009.05.022. Epub 2009 May 14.

  PMID: 19446645 BACKGROUND

• Gomez AD, Bayly PV, Butman JA, Pham DL, Prince JL, Knutsen AK. Group characterization of impact-induced, in vivo human brain kinematics. J R Soc Interface. 2021 Jun;18(179):20210251. doi: 10.1098/rsif.2021.0251. Epub 2021 Jun 23.

  PMID: 34157896 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Daniel S Reich, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 30, 2012
• First Posted: July 4, 2012
• Study Start: July 4, 2012
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)