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Protocol Details

Estimation of Brain Biomechanics using MRI

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-CC-0139

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

-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)

EXCLUSION CRITERIA:

-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.


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Citations:

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.

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.

Brun CC, Lepor(SqrRoot)(Copyright) 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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

John A. Butman, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 1C373
10 CENTER DR
BETHESDA MD 20892
(301) 402-5827
jbutman@nih.gov

Tracy L. Cropper, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C512
10 Center Drive
Bethesda, Maryland 20892
(301) 402-6132
tcropper@cc.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01633268

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