Healthy VolunteerNCT01633268
Estimating Brain Biomechanics Using MRI
An observational study of Healthy Volunteer and Traumatic Brain Injury, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Traumatic Brain Injury, Brain Mapping
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2012to 21 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers between age 18 and 65.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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 18-65.
Read more
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.
...
Read the 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. Using the developed imaging techniques above, we will acquire a sufficient number of data sets to create templates of the average brain response and stiffness based on age and sex. Anonymized raw and processed data will be made publicly available to improve computational models of brain biomechanics.
Study Population
Measurements will be performed on 194 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. Additionally, we will use a type of MRI called magnetic resonance elastography (MRE), which measures brain motion in response to mild head vibration, to investigate brain stiffness.
Outcome measures
This project is a study evaluating the potential of extracting three-dimensional estimates of brain deformation, such as strain measurements and stiffness, using MR imaging. A primary outcome of this project will be MRI techniques for characterizing 3-D brain biomechanics. The techniques will be evaluated by applying the protocol to human subjects, followed by preliminary quantification of the reproducibility and stability of deformation and stiffness measurements. Acquired data will be made publicly available for use by the research community.
- Conditions
- Healthy Volunteer, Traumatic Brain Injury, Brain Mapping, Craniocerebral Trauma, Magnetic Resonance Imaging
- Keywords
- MRI (Magnetic Resonance Imaging), Traumatic Brain Injury, Natural History
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy men and women aged 18-65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 of study
Secondary outcomes (1)
Measure of preliminary database of brain deformation
A preliminary database of brain deformation measurements from a healthy cohort will allow initial characterization of the variability of brain response across sex and age.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study start4 Jul 2012
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Reich, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633268
- Sponsor's protocol ID
- 120139
- Other IDs
- 12-CC-0139
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2012
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are working on deciding if we will share IPD.
Publications
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.
PubMed 8073323Bayly 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.
PubMed 16083352Brun 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.
PubMed 19446645Gomez 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.
PubMed 34157896
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Brain Biomechanics Using MRI
- ClinicalTrials.gov ID
- NCT01633268
- Acronym / sponsor ID
- 120139
- Conditions
- Healthy Volunteer, Traumatic Brain Injury, Brain Mapping, Craniocerebral Trauma, Magnetic Resonance Imaging
- Keywords
- MRI (Magnetic Resonance Imaging), Traumatic Brain Injury, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 4 Jul 2012 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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. Using the developed imaging techniques above, we will acquire a sufficient number of data sets to create templates of the average brain response and stiffness based on age and sex. Anonymized raw and processed data will be made publicly available to improve computational models of brain biomechanics.
Study Population
Measurements will be performed on 194 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. Additionally, we will use a type of MRI called magnetic resonance elastography (MRE), which measures brain motion in response to mild head vibration, to investigate brain stiffness.
Outcome measures
This project is a study evaluating the potential of extracting three-dimensional estimates of brain deformation, such as strain measurements and stiffness, using MR imaging. A primary outcome of this project will be MRI techniques for characterizing 3-D brain biomechanics. The techniques will be evaluated by applying the protocol to human subjects, followed by preliminary quantification of the reproducibility and stability of deformation and stiffness measurements. Acquired data will be made publicly available for use by the research community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy men and women aged 18-65 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers between age 18 and 65.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
technical development of a method for providing three-dimensional measurements 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 deformation measurements
1 secondary outcome
Measure of preliminary database of brain deformation
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 8073323Allen 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.
- Background: PubMed 16083352Bayly 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.
- Background: PubMed 19446645Brun 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.
- Derived from this study: PubMed 34157896Gomez 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are working on deciding if we will share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Reich, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Traumatic Brain Injury, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical development of a method for providing three-dimensional measurements of brain biomechanics in vivo using MR imaging. (time frame: Day 1 of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633268, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.