Imaging Characterization of the Biomechanical Coupling of Brain and Skull

NCT05675423 | Withdrawn

• 2 other identifiers: 10000736000736-CC
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Traumatic Brain Injury (Tbi); Traumatic Meningeal Enhancement (Tme)

Keywords

Traumatic Meningeal Injury; Traumatic Meningeal Enhancement; Traumatic Brain Injury; Fluid Attenuated Inversion Recovery; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study

Secondary Outcomes (1)

• Measure skull brain coupling

  End of study

Study Arms (3)

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.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

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 (3)

• 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.

  PMID: 30029236 BACKGROUND

• Roth 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.

  PMID: 24317693 BACKGROUND

• Chiara 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.

  PMID: 27215444 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• John A Butman, 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: January 6, 2023
• First Posted: January 9, 2023
• Study Start: September 12, 2024
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Locations

US (1)