Traumatic Brain InjuryNCT01922531
Defining Axonal Injury in Children With Mild Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients presenting to a Pediatric Emergency Department
Who may be able to join
- 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:
- Subjects with isolated extremity trauma requiring radiography and an Abbreviated Injury Scale (AIS) of < 3 (AIS; American Association for Automotive Medicine, 1990)123 will be included in the study. The presence of a fracture on the x-ray is not a requirement for inclusion. Subjects can not require immediate surgery for care. We will attempt to match based on gender and age (+/- 365 days within the included age range 11-16); yet, we will enroll consecutive eligible patients meeting inclusion/exclusion criteria.Subjects must not have any evidence of head trauma / facial trauma or symptoms of concussion (such as LOC, amnesia, confusion). This information must be corroborated with a reliable witness or the parent and the treating physician. Subjects must have normal neurologic exams and must not require a head CT as a part of the clinical care. Subjects may be prescribed narcotics and/or opiates prescribed for pain in the ED will be allowed IF the subject agrees to refrain from taking the medication for at least 4 hours prior to completing the neurobehavioral testing at follow-up. Subjects must meet the same CBCL score and ADHD definition as listed in the mTBI group.
Who cannot join
- mTBI Group: Exclusion Criteria: Children <11 or >16 years old and subjects and/or the families do not speak and read English will be excluded. Subjects with a score of 65 or more on the CBCL will be excluded due to probable pre-existing impairment. Any subject who has an altered mental status due to the ingestion of substances of abuse or alcohol or who are prescribed a drug that impairs cognition (e.g., benzodiazepines, antipsychotics, or opiates such as those listed (but not limited to) in Appendix L). Subjects will be excluded if they have a prior history of concussion, pre-existing neurologic impairment (stroke, prior TBI requiring ED visit or hospitalization, CSF shunt, brain tumor), pre-existing cognitive disorders (seizure disorder, mental retardation), psychological problems or developmental delay. Subjects with the following illnesses will also be excluded: bleeding or coagulation disorders, cancer (who are currently undergoing treatment), HIV/AIDS, schizophrenia, multiple sclerosis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), amyotrophic lateral sclerosis (ALS), Alzheimer's Disease, Creutzfeldt-Jakob Disease, and Krabbe Disease. Subjects will be excluded if they have the diagnosis of ADHD and require 2 or more medications for control or they have a T-score of 50 or greater on the DSM Oriented Scale for Attention Deficit / Hyperactivity Disorder. Subjects will be excluded if they are on any medication typically prescribed for ADHD but do not carry the diagnosis of ADHD. Subjects will be excluded if they have any condition that precluded them from undergoing magnetic resonance imaging as detailed in Appendix L. These include having an implanted medical devices (i.e., cardiac pace maker, hearing aid, or other implant); having metal in the body that does not meet criteria for MRI machines (i.e. braces, plates, screws; since some types of metal are not responsive to the magnet and are permitted, the eligibility for MRI will be investigated in each such case to ensure safety); having non-removable jewelry or body piercing; pregnancy; known claustrophobia; extreme obesity (due to physical limitation of the magnet). Subjects with one extracranial (organ group) injury with an AIS score of > 2 or 2 or more extracranial (i.e. 2 or more organ groups) injuries will be excluded, those with multiple injuries to one organ group (ie, skin abrasion on more than 1 extremity) will still be eligible.
- Orthopedic Injury Control Group:
- Subjects who present with an orthopedic injury, as well as head trauma or signs or symptoms of mTBI will be excluded. Subjects who do not have a reliable witness to determine that there was no loss of consciousness, amnesia, or confusion related to the injury will be excluded. Subjects who are enrolled then subsequently receive a Head CT will have enrollment discontinued. Subjects who are prescribed a drug that impairs cognition (e.g., benzodiazepines, antipsychotics, opiates) will be excluded. Any inability or unwillingness to complete study procedures including follow up procedures will be excluded. Subjects will not be eligible to serve as controls if they cannot use a computer mouse due to their injury. Patients must not have any of the other exclusion criteria listed for the mTBI group (ie, CBCL scores, ADHD diagnosis, pre-existing conditions,MRI Contraindications)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the detailed description
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
- Traumatic Brain Injury
- Keywords
- mTBI, Mild Traumatic Brain Injury, Axonal Injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
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 |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in mean FA
The primary analysis was to test for significant differences in mean Fractional Anisotropy in the Corpus Callosum between the mild traumatic brain injured patients and orthopedic controls.
Measured: 72 hours post enrollment
Secondary outcomes (1)
Functional Outcomes following mTBI
Four meausres were used to assess functional outcomes following mTBI. These were completed at 1 week and 1 month post injury.
Measured: 1 week and 1 month post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn Babcock, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922531
- Sponsor's protocol ID
- CCHMC001
- Status last verified
- Aug 2013
- First submitted
- 12 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Axonal Injury in Children With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01922531
- Acronym / sponsor ID
- CCHMC001
- Conditions
- Traumatic Brain Injury
- Keywords
- mTBI, Mild Traumatic Brain Injury, Axonal Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Aug 2013 (estimated)
- 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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients presenting to a Pediatric Emergency Department
Key inclusion criteria (3 listed)
- 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).
- Subjects with isolated extremity trauma requiring radiography and an Abbreviated Injury Scale (AIS) of < 3 (AIS; American Association for Automotive Medicine, 1990)123 will be included in the study. The presence of a fracture on the x-ray is not a requirement for inclusion. Subjects can not require immediate surgery for care. We will attempt to match based on gender and age (+/- 365 days within the included age range 11-16); yet, we will enroll consecutive eligible patients meeting inclusion/exclusion criteria.Subjects must not have any evidence of head trauma / facial trauma or symptoms of concussion (such as LOC, amnesia, confusion). This information must be corroborated with a reliable witness or the parent and the treating physician. Subjects must have normal neurologic exams and must not require a head CT as a part of the clinical care. Subjects may be prescribed narcotics and/or opiates prescribed for pain in the ED will be allowed IF the subject agrees to refrain from taking the medication for at least 4 hours prior to completing the neurobehavioral testing at follow-up. Subjects must meet the same CBCL score and ADHD definition as listed in the mTBI group.
Key exclusion criteria (3 listed)
- mTBI Group: Exclusion Criteria: Children <11 or >16 years old and subjects and/or the families do not speak and read English will be excluded. Subjects with a score of 65 or more on the CBCL will be excluded due to probable pre-existing impairment. Any subject who has an altered mental status due to the ingestion of substances of abuse or alcohol or who are prescribed a drug that impairs cognition (e.g., benzodiazepines, antipsychotics, or opiates such as those listed (but not limited to) in Appendix L). Subjects will be excluded if they have a prior history of concussion, pre-existing neurologic impairment (stroke, prior TBI requiring ED visit or hospitalization, CSF shunt, brain tumor), pre-existing cognitive disorders (seizure disorder, mental retardation), psychological problems or developmental delay. Subjects with the following illnesses will also be excluded: bleeding or coagulation disorders, cancer (who are currently undergoing treatment), HIV/AIDS, schizophrenia, multiple sclerosis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), amyotrophic lateral sclerosis (ALS), Alzheimer's Disease, Creutzfeldt-Jakob Disease, and Krabbe Disease. Subjects will be excluded if they have the diagnosis of ADHD and require 2 or more medications for control or they have a T-score of 50 or greater on the DSM Oriented Scale for Attention Deficit / Hyperactivity Disorder. Subjects will be excluded if they are on any medication typically prescribed for ADHD but do not carry the diagnosis of ADHD. Subjects will be excluded if they have any condition that precluded them from undergoing magnetic resonance imaging as detailed in Appendix L. These include having an implanted medical devices (i.e., cardiac pace maker, hearing aid, or other implant); having metal in the body that does not meet criteria for MRI machines (i.e. braces, plates, screws; since some types of metal are not responsive to the magnet and are permitted, the eligibility for MRI will be investigated in each such case to ensure safety); having non-removable jewelry or body piercing; pregnancy; known claustrophobia; extreme obesity (due to physical limitation of the magnet). Subjects with one extracranial (organ group) injury with an AIS score of > 2 or 2 or more extracranial (i.e. 2 or more organ groups) injuries will be excluded, those with multiple injuries to one organ group (ie, skin abrasion on more than 1 extremity) will still be eligible.
- Subjects who present with an orthopedic injury, as well as head trauma or signs or symptoms of mTBI will be excluded. Subjects who do not have a reliable witness to determine that there was no loss of consciousness, amnesia, or confusion related to the injury will be excluded. Subjects who are enrolled then subsequently receive a Head CT will have enrollment discontinued. Subjects who are prescribed a drug that impairs cognition (e.g., benzodiazepines, antipsychotics, opiates) will be excluded. Any inability or unwillingness to complete study procedures including follow up procedures will be excluded. Subjects will not be eligible to serve as controls if they cannot use a computer mouse due to their injury. Patients must not have any of the other exclusion criteria listed for the mTBI group (ie, CBCL scores, ADHD diagnosis, pre-existing conditions,MRI Contraindications)
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
Differences in mean FA
Time frame: 72 hours post enrollment
The primary analysis was to test for significant differences in mean Fractional Anisotropy in the Corpus Callosum between the mild traumatic brain injured patients and orthopedic controls.
1 secondary outcome
Functional Outcomes following mTBI
Time frame: 1 week and 1 month post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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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.
Lynn Babcock, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Aug 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in mean FA (time frame: 72 hours post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2013.