Traumatic Brain Injury (Tbi)NCT05675423
Imaging Characterization of the Biomechanical Coupling of Brain and Skull
An observational study of Traumatic Brain Injury (Tbi) and Traumatic Meningeal Enhancement (Tme), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Traumatic brain injury (TBI) affects over 1.7 million people in the United States each year. Many cases are mild, but people with a history of TBI may have long-term symptoms; they are also known to be more susceptible to future concussions. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (Tbi), Traumatic Meningeal Enhancement (Tme)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to 12 Sep 2024
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects 21-65 years old, healthy volunteers, subjects with history of TBI but no history of TMI and subjects with a history of TMI.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 21-65.
- Deemed medically safe for study participation by the subjects attending physician
- Within the TBI group, subjects must have a history of mild TBI at time of initial presentation, defined as Glasgow Coma Scale score of 13-15, loss of consciousness < 30 minutes, and normal structural imaging on CT. Subjects should be less than 10 years from time of injury.
- Within the TME group, in addition to the TBI characteristics above, subjects should additionally, have presented for TME at the time of initial presentation, evaluated by postcontrast FLAIR imaging.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Within the healthy control group, any history of clinically diagnosed TBI.
- Other known conditions outside of TBI that may affect brain anatomy.
- Inner ear problems causing dizziness.
- Having a height or weight not supported by the MRI scanner.
- Contraindications to MRI (e.g. pacemaker, pregnancy, claustrophobia).
- Unwillingness to remove cosmetic metal (e.g. piercings) for the MRI.
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: Imaging Characterization of the Biomechanical Coupling of Brain and Skull: An Observational Study
Background:
Traumatic brain injury (TBI) affects over 1.7 million people in the United States each year. Many cases are mild, but people with a history of TBI may have long-term symptoms; they are also known to be more susceptible to future concussions. Researchers are working to understand how TBI affects tissues in and around the brain over the long term. This natural history study will investigate how a TBI may change the stiffness of the brain and its surrounding connective tissues.
Read more
Objective:
To see how the brain and connective tissues respond to small head movements in people with and without a prior TBI.
Eligibility:
People aged 21 to 65 years with a history of TBI. People with no history of TBI are also needed.
Design:
Participants will have 1 clinic visit that will last about 4 hours.
Participants will have a physical exam. They answer questions to make sure it is safe for them to have a magnetic resonance imaging (MRI) scan of their brain.
They will have an MRI scan in 2 parts.
During the first part, participants will lie on a table that slides into a large tube. They will hear loud knocking noises. They may wear earplugs or earmuffs. They will lie still for 15 minutes at a time. They will be in the tube for about up to 75 minutes.
The second part is called magnetic resonance elastography (MRE). Participants will lie with their head on a pillow that vibrates gently. This test will take 10 minutes.
Participants will answer questions about how they feel 1 or 2 days after the procedure.
Read the detailed description
Study Description:
The study will characterize the biomechanical coupling of the brain to the skull in human volunteers with and without a history of traumatic brain injury (TBI) using magnetic resonance elastography (MRE). MRE uses the MR scanner to measure the relative motion of brain and skull while the head is vibrated at specified frequencies.
Objectives:
Our objectives are:
- Apply MRE to characterize the skull-brain interface in 25 mild TBI patients with a history of acute TME (TME+), 25 TME-patients (mild TBI patients without TME) and 25 healthy controls.
- To determine whether local shear strain measures within the cortex during MRE are altered in TME+ subjects. Up to 10 additional healthy controls will be recruited for technical development of imaging protocols.
Endpoints:
Study endpoints are the completion of the MRE visit for each volunteer. The MRE data will be used to characterize the S-BI using the amplitudes and temporal delays of translation and rotation across the S-BI.
- Keywords
- Traumatic Meningeal Injury, Traumatic Meningeal Enhancement, Traumatic Brain Injury, Fluid Attenuated Inversion Recovery, Natural History
- Medical subject headings
- Brain Injuries, Traumatic
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 |
|---|---|---|
| 25 subjects with a history of TBI but no history of TMI | 25 subjects with a history of TBI but no history of TMI. | |
| 25 subjects with a history of TMI | 25 subjects with a history of TMI. | |
| 35 healthy controls | 35 healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain MRE images
MRE images will be processed to estimate global differences in the amplitudes and temporal delays of translation and rotation between brain and skull. Temporal delay reflects the lag in motion between the skull and brain, with a lower delay reflecting tighter coupling of motion.
Measured: End of study
Secondary outcomes (1)
Measure skull brain coupling
Local measures of skull-brain coupling will be measured from MRE using octahedral shear strain, with a focus at the cortical surface. Shear strains reflect the ratio of deformation to its original state, with higher strains representing higher deformation. No attachments between the brain and skull would represent a pure slip condition, resulting in negligible strain and infinitely large temporal delays.
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 posted9 Jan 2023
- Study start12 Sep 2024
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Why it stopped: PI has retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (Tbi)Studies 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
- 0 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
- John A Butman, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675423
- Sponsor's protocol ID
- 10000736
- Other IDs
- 000736-CC
- Status last verified
- Sep 2024
- First submitted
- 6 Jan 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan DD, Knutsen AK, Lu YC, Yang SH, Magrath E, Wang WT, Bayly PV, Butman JA, Pham DL. Statistical Characterization of Human Brain Deformation During Mild Angular Acceleration Measured In Vivo by Tagged Magnetic Resonance Imaging. J Biomech Eng. 2018 Oct 1;140(10):1010051-10100513. doi: 10.1115/1.4040230.
PubMed 30029236Roth TL, Nayak D, Atanasijevic T, Koretsky AP, Latour LL, McGavern DB. Transcranial amelioration of inflammation and cell death after brain injury. Nature. 2014 Jan 9;505(7482):223-8. doi: 10.1038/nature12808. Epub 2013 Dec 8.
PubMed 24317693Chiara Ricciardi M, Bokkers RP, Butman JA, Hammoud DA, Pham DL, Warach S, Latour LL. Trauma-Specific Brain Abnormalities in Suspected Mild Traumatic Brain Injury Patients Identified in the First 48 Hours after Injury: A Blinded Magnetic Resonance Imaging Comparative Study Including Suspected Acute Minor Stroke Patients. J Neurotrauma. 2017 Jan 1;34(1):23-30. doi: 10.1089/neu.2015.4338. Epub 2016 Jun 10.
PubMed 27215444
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Characterization of the Biomechanical Coupling of Brain and Skull: An Observational Study
- ClinicalTrials.gov ID
- NCT05675423
- Acronym / sponsor ID
- 10000736
- Keywords
- Traumatic Meningeal Injury, Traumatic Meningeal Enhancement, Traumatic Brain Injury, Fluid Attenuated Inversion Recovery, Natural History
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI has retired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 9 Jan 2023 (actual)
- 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.
Background:
Traumatic brain injury (TBI) affects over 1.7 million people in the United States each year. Many cases are mild, but people with a history of TBI may have long-term symptoms; they are also known to be more susceptible to future concussions. Researchers are working to understand how TBI affects tissues in and around the brain over the long term. This natural history study will investigate how a TBI may change the stiffness of the brain and its surrounding connective tissues.
Objective:
To see how the brain and connective tissues respond to small head movements in people with and without a prior TBI.
Eligibility:
People aged 21 to 65 years with a history of TBI. People with no history of TBI are also needed.
Design:
Participants will have 1 clinic visit that will last about 4 hours.
Participants will have a physical exam. They answer questions to make sure it is safe for them to have a magnetic resonance imaging (MRI) scan of their brain.
They will have an MRI scan in 2 parts.
During the first part, participants will lie on a table that slides into a large tube. They will hear loud knocking noises. They may wear earplugs or earmuffs. They will lie still for 15 minutes at a time. They will be in the tube for about up to 75 minutes.
The second part is called magnetic resonance elastography (MRE). Participants will lie with their head on a pillow that vibrates gently. This test will take 10 minutes.
Participants will answer questions about how they feel 1 or 2 days after the procedure.
Detailed description
Study Description:
The study will characterize the biomechanical coupling of the brain to the skull in human volunteers with and without a history of traumatic brain injury (TBI) using magnetic resonance elastography (MRE). MRE uses the MR scanner to measure the relative motion of brain and skull while the head is vibrated at specified frequencies.
Objectives:
Our objectives are:
- Apply MRE to characterize the skull-brain interface in 25 mild TBI patients with a history of acute TME (TME+), 25 TME-patients (mild TBI patients without TME) and 25 healthy controls.
- To determine whether local shear strain measures within the cortex during MRE are altered in TME+ subjects. Up to 10 additional healthy controls will be recruited for technical development of imaging protocols.
Endpoints:
Study endpoints are the completion of the MRE visit for each volunteer. The MRE data will be used to characterize the S-BI using the amplitudes and temporal delays of translation and rotation across the S-BI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 subjects with a history of TBI but no history of TMI | – | –25 subjects with a history of TBI but no history of TMI. |
| 25 subjects with a history of TMI | – | –25 subjects with a history of TMI. |
| 35 healthy controls | – | –35 healthy controls. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 21-65 years old, healthy volunteers, subjects with history of TBI but no history of TMI and subjects with a history of TMI.
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 21-65.
- Deemed medically safe for study participation by the subjects attending physician
- Within the TBI group, subjects must have a history of mild TBI at time of initial presentation, defined as Glasgow Coma Scale score of 13-15, loss of consciousness < 30 minutes, and normal structural imaging on CT. Subjects should be less than 10 years from time of injury.
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Within the healthy control group, any history of clinically diagnosed TBI.
- Other known conditions outside of TBI that may affect brain anatomy.
- Inner ear problems causing dizziness.
- Having a height or weight not supported by the MRI scanner.
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
Obtain MRE images
Time frame: End of study
MRE images will be processed to estimate global differences in the amplitudes and temporal delays of translation and rotation between brain and skull. Temporal delay reflects the lag in motion between the skull and brain, with a lower delay reflecting tighter coupling of motion.
1 secondary outcome
Measure skull brain coupling
Time frame: End of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Background: PubMed 30029236Chan DD, Knutsen AK, Lu YC, Yang SH, Magrath E, Wang WT, Bayly PV, Butman JA, Pham DL. Statistical Characterization of Human Brain Deformation During Mild Angular Acceleration Measured In Vivo by Tagged Magnetic Resonance Imaging. J Biomech Eng. 2018 Oct 1;140(10):1010051-10100513. doi: 10.1115/1.4040230.
- Background: PubMed 24317693Roth TL, Nayak D, Atanasijevic T, Koretsky AP, Latour LL, McGavern DB. Transcranial amelioration of inflammation and cell death after brain injury. Nature. 2014 Jan 9;505(7482):223-8. doi: 10.1038/nature12808. Epub 2013 Dec 8.
- Background: PubMed 27215444Chiara Ricciardi M, Bokkers RP, Butman JA, Hammoud DA, Pham DL, Warach S, Latour LL. Trauma-Specific Brain Abnormalities in Suspected Mild Traumatic Brain Injury Patients Identified in the First 48 Hours after Injury: A Blinded Magnetic Resonance Imaging Comparative Study Including Suspected Acute Minor Stroke Patients. J Neurotrauma. 2017 Jan 1;34(1):23-30. doi: 10.1089/neu.2015.4338. Epub 2016 Jun 10.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
John A Butman, 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 Traumatic Brain Injury (Tbi) and Traumatic Meningeal Enhancement (Tme), 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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Oct 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Obtain MRE images (time frame: End 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 NCT05675423, which also lists 3 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 3 Oct 2024.