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NCT01633268 · ClinicalTrials.gov registry record
Estimating Brain Biomechanics Using MRI
A clinical trial of Traumatic Brain Injury and Healthy Volunteer, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 101
- Enrollment target
- 1
- Study location
NCT01633268: Completed study of Traumatic Brain Injury and Healthy Volunteer, sponsored by National Institutes of Health Clinical Center (CC).
NCT01633268 is a study of Traumatic Brain Injury and Healthy Volunteer that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 101 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01633268, a study of Traumatic Brain Injury and Healthy Volunteer, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 101 participants
- Enrollment target
- 1
- Study location
Study 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. 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 sequenc
Primary Outcome
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
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2012-07-04 |
| Est. Completion | 2025-11-21 |
What the finished NCT01633268 record still lists
NCT01633268 is an observational study that tracks outcomes without assigning an intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (64% lower).
The record links to 5 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 0 interventions.
NCT01633268 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01633268 about?
NCT01633268 is a clinical study titled "Estimating 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 ...
What is the current status of trial NCT01633268?
This trial is currently completed. The enrollment target is 101 participants. The study started on 2012-07-04. Estimated completion is 2025-11-21.
What conditions does trial NCT01633268 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Healthy Volunteer, Magnetic Resonance Imaging, Craniocerebral Trauma, Brain Mapping.
Who is sponsoring clinical trial NCT01633268?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01633268 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01633268's enrollment target sits among peer trials
101 70th of 171 higher than 102 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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