Defining Axonal Injury in Children With Mild Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To measure Axonal Injury in children with mild traumatic brain injury enrolled in an Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: To determine if children with mild traumatic brain injury (mTBI) have acute axonal injury defined by disruption of diffusion of water in white matter using diffusion tensor imaging (DTI) as compared to orthopedic injury (OI) controls.

Methods: Children ages 11-16 years who presented within 6 hours of either a mTBI or an isolated OI were recruited from the emergency department (ED). Patients had Diffusion Tensor Imaging (DTI) study performed within 96 hours of injury. Voxel based analysis approach was used to quantify the group differences for common DTI measures. In the ED and at the time of the scan, symptom burden was measured using the post concussion symptom scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

mTBI Mild Traumatic Brain Injury Axonal Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild Traumatic Brain Injury

These were patients who presented to the ER within 6 hours of a witnessed head injury. Patients were also eligible if the patient had a self-reported head injury with evidence of head trauma.

No interventions assigned to this group

Orthopedic Injury

Patients were eligible as an orthopedic injured control who presented to the ER within 6 hours of an isolated extremity trauma that radiography and an Abbreviated Injury Scale (AIS) of less than or equal to 3.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

mTBI group: Inclusion: Children between the ages of \>11 to \< 16 years who present within 6 hours of injury with a witnessed head injury. A patient may have a self-reported injury to the head but there must also be evidence of head trauma on exam to be eligible for the study. Subjects must meet the clinical definition of mTBI from the American Congress of Rehabilitation Medicine122: A blow to the head or acceleration/deceleration movement of the head resulting in one or more of the following: i. loss of consciousness \<30 minutes, ii. amnesia \<24 hours, iii. any alteration in mental state at the time of the injury. Subjects without witnessed LOC/amnesia but with demonstrable amnesia in the ED are eligible. Subject must have GCS of 13-15 at the time of arrival in the ED. Subject may be enrolled prior to CT (if completed). Subjects should only have up to 1 other minor extracranial injury defined by an Abbreviated Injury Severity Scale \< 1 to that region (AIS; American Association for Automotive Medicine, 1990). Subjects will be included if they have multiple injuries that affect only 1 body system as noted in the AIS (ie, subjects who sustain skin abrasions to more than 1 body region as a result of injury but do not meet exclusion based on injury severity) Subjects and their families must be able to speak and read English. Subjects must agree to have blood drawn in the ED, and to return three times as an outpatient for repeat testing. Subjects are still eligible if they are admitted to the hospital. Subjects must have a score of less than 65 on the CBCL to be included in the study to limit possible co-morbidities. Children with a diagnosis of Attention Deficit / Hyperactivity Disorder (ADHD) will be included as long as they meet the following criteria: physician diagnosed, controlled by only one ADHD medication, and have a T-score of less than 50 on the DSM Oriented Scale for Attention Deficit / Hyperactivity Disorder (Sub-Category of CBCL).

Orthopedic Injury Control Group:

Exclusion Criteria

Orthopedic Injury Control Group:

Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lynn Babcock, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCHMC001

Identifier Type: -

Identifier Source: org_study_id