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NCT05675423

Imaging Characterization of the Biomechanical Coupling of Brain and Skull

Withdrawn Last updated 3 October 2024
What this trial tests

trial in Traumatic Brain Injury (Tbi). Withdrawn.

Timeline
12 September 2024
Primary endpoint
12 September 2024
12 September 2024

Quick facts

Lead sponsorNational Institutes of Health Clinical Center (CC)
StatusWithdrawn
Study typeOBSERVATIONAL
Start date12 September 2024
Primary completion12 September 2024
Estimated completion12 September 2024
Sites1 location across United States

Conditions studied

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 21 to 65, any sex, with Traumatic Brain Injury (Tbi) or Traumatic Meningeal Enhancement (Tme). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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