Mild Traumatic Brain InjuryNCT00715949
Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population
An observational study of Mild Traumatic Brain Injury and Concussion, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Brain injuries from trauma are common in children, often resulting in death and disability. Most brain injuries are minor, yet their treatment can be challenging. Because there are many different scales used to characterize the severity of brain injury, there is no consensus regarding how to manage patients with minor… Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Concussion
- What is being tested?
- Immediate Post-concussion Assessment and Cognitive Testing
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric blunt trauma patients (age 11-19 years) admitted to The Children's Hospital of Philadelphia for treatment of mild traumatic brain injury
Who may be able to join
- Pediatric blunt trauma patients (age 11-19 years) admitted for treatment of minor traumatic brain injury will be eligible for inclusion in the study. For the purposes of this study, mild traumatic brain injury will include patients with a Glasgow Coma Scale (GCS) of 14-15 upon arrival in the trauma receiving area. This may include those patients with and without abnormalities on head CT scans.
- Children will be included regardless of race, gender or ethnicity. The distribution of gender, race, and ethnicity is expected to reflect that of the trauma population at The Children's Hospital of Philadelphia
Who cannot join
- Patients with penetrating injuries as well as patients treated and released from the emergency room will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Neurocognitive Evaluation of Minor Traumatic Brain Injury in the Hospitalized Pediatric Population
Brain injuries from trauma are common in children, often resulting in death and disability. Most brain injuries are minor, yet their treatment can be challenging. Because there are many different scales used to characterize the severity of brain injury, there is no consensus regarding how to manage patients with minor brain injuries. Specifically, there is no agreement on recommendations regarding the safety of return to activities following injury. In young athletes with minor brain injuries (i.e. concussions) there is strong data suggesting that return to baseline neurologic function is often delayed by days or weeks. Children allowed to return to activities too soon may be at a higher risk for a second concussion, may delay recovery or, in rare cases, die. Researchers have designed a computer-based testing system (ImPACT©) to objectively test for neurologic deficits following injury. This test has been used primarily in athletes following a concussion but is also applicable to children with brain injuries from non-sports related traumas. We propose to utilize this testing in pediatric patients admitted to the hospital with minor brain injury. The test would be administered at the time of the hospitalization as well as in the outpatient trauma clinic at the time of routine follow up. The test would allow us to determine if there are neurologic deficits, potentially subclinical, in these brain injured patients and how quickly they recover from their injuries. If successful, the testing will likely be useful in other clinical settings such as the primary care office (e.g. pediatrician), specialty care office (e.g. sports medicine), or emergency room to determine if an injured child requires additional intervention.
Read the detailed description
BACKGROUND
Head injuries are a frequent source of morbidity and the most common source of mortality in the pediatric trauma population. [1] It is estimated that head injuries result in more than 500,000 emergency department visits, 95,000 hospital admissions and 7,000 deaths in the pediatric age-groups. [1] Despite the magnitude of these numbers, they likely underestimate the problem, as many injured children are not brought to medical attention. Fortunately, most head injuries (75%) are classified as minor. [2] While major head injuries obviously pose a greater threat to life for the individual, the sheer volume of minor head injuries, as well as the potential for enduring neurologic sequelae, makes them a significant public health problem. Management of this large group of patients can be most challenging due to a lack of consensus in the health care community regarding the definition of minor traumatic brain injury, the ideal assessment modality for the injured child and recommendations for return to activity following a brain injury. Return to play recommendations have traditionally been based on the grade of concussion and the clinical exam. However given the large number of concussion grading scales in existence and the subtle nature of many of the neurologic deficits, standard recommendations have been lacking. Further still, the tremendous variability in time to full recovery exhibited by brain-injured children make generic guidelines naïve.
While the recovery from head injury in children is variable and difficult to predict, the desire to return to activity however, is near constant. Determining when it is safe to return to play is thus important. Recent literature has highlighted the perils of premature return to activities (most notably contact sports) for children with traumatic brain injury. [3-6] Dangers include prolongation of post-concussive symptoms, increased risk of recurrence of injury and death.[3-6] Further, these dangers may be more common in the younger athletes.[7] However, there is evidence that even non-contact, exertional activities may be detrimental if initiated too quickly. It was the observation of the First International Conference on Concussion in Sport that no previously published guidelines for management of concussion was adequate for assessment of all concussions. Further, they recognized the utility of neuropsychological testing in understanding the injury and determining management for the concussed patient. [8] Unfortunately, the majority of treating clinicians have few tools available to help determine when it is appropriate for the individual to return to activities. One such tool that has been used extensively and effectively in the head injured athlete is the Immediate Post concussion Assessment and Cognitive Testing (ImPACT©) program. This is an interactive software program originally designed to assess subjective and objective cognitive abilities of the head injured athlete. The program has been validated for use in sports-related concussion. [9, 10] Studies of concussed athletes have demonstrated a much slower return to baseline than previously had been appreciated. [11] Further, the younger athletes (high school vs. college or professional) were the slowest to return to the baseline. [7] This program has proven quite useful in determining the optimal time to return to activities in the population of head injured athletes by providing objective data upon which to base recommendations.
The same decisions facing clinicians treating children with sports related head injuries also exist for other non-sports related mechanisms (e.g. motor vehicle collisions, falls). Motor vehicle related causes and falls are the most common sources of traumatic brain injury in children. [12] Sports and recreation account for less than 10% of hospitalized minor traumatic brain injuries. Non-sports related traumatic brain injuries are often more severe but can be equally as difficult to assess. Anecdotal evidence collected by the researchers with the ImPACT© team suggests that the neurocognitive testing would be similarly efficacious in the assessment of non-sports related brain injured patients.
Utilizing a treatment algorithm that involves neurocognitive testing at the level of the individual is most likely to effectively determine the suitability to return to activities and the need for specialty intervention.
SPECIFIC AIMS
- To assess the feasibility of inpatient bedside neurocognitive testing of pediatric patients with minor traumatic brain injury.
- To establish if neurocognitive deficits exist, and to what extent, in the cohort of hospitalized pediatric patients with minor traumatic brain injury.
- To document the timing and extent of recovery for pediatric traumatic brain injury through follow-up neurocognitive testing.
- Conditions
- Mild Traumatic Brain Injury, Concussion
- Being tested
- Immediate Post-concussion Assessment and Cognitive Testing
- Keywords
- traumatic brain injury, pediatric, neurocognitive, concussion
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Post-concussion Assessment and Cognitive TestingOther
ImPACT© utilizes a battery of neurocognitive tests to assess neurologic deficits.
| Study group | Role | What they receive |
|---|---|---|
| Mild Traumatic Brain Injury (MTBI) admits | admitted pediatric patients with mild traumatic brain injury (concussion) Receives: Other: Immediate Post-concussion Assessment and Cognitive Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.
In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).
Measured: Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.
Secondary outcomes (1)
To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.
Measured: study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Michael L. Nance, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715949
- Sponsor's protocol ID
- 2005-11-4572
- Status last verified
- Apr 2015
- First submitted
- 14 Jul 2008
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nance ML, Polk-Williams A, Collins MW, Wiebe DJ. Neurocognitive evaluation of mild traumatic brain injury in the hospitalized pediatric population. Ann Surg. 2009 May;249(5):859-63. doi: 10.1097/SLA.0b013e3181a41ae5.
PubMed 19387313
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Evaluation of Minor Traumatic Brain Injury in the Hospitalized Pediatric Population
- ClinicalTrials.gov ID
- NCT00715949
- Acronym / sponsor ID
- 2005-11-4572
- Conditions
- Mild Traumatic Brain Injury, Concussion
- Keywords
- traumatic brain injury, pediatric, neurocognitive, concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Pennsylvania
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 15 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain injuries from trauma are common in children, often resulting in death and disability. Most brain injuries are minor, yet their treatment can be challenging. Because there are many different scales used to characterize the severity of brain injury, there is no consensus regarding how to manage patients with minor brain injuries. Specifically, there is no agreement on recommendations regarding the safety of return to activities following injury. In young athletes with minor brain injuries (i.e. concussions) there is strong data suggesting that return to baseline neurologic function is often delayed by days or weeks. Children allowed to return to activities too soon may be at a higher risk for a second concussion, may delay recovery or, in rare cases, die. Researchers have designed a computer-based testing system (ImPACT©) to objectively test for neurologic deficits following injury. This test has been used primarily in athletes following a concussion but is also applicable to children with brain injuries from non-sports related traumas. We propose to utilize this testing in pediatric patients admitted to the hospital with minor brain injury. The test would be administered at the time of the hospitalization as well as in the outpatient trauma clinic at the time of routine follow up. The test would allow us to determine if there are neurologic deficits, potentially subclinical, in these brain injured patients and how quickly they recover from their injuries. If successful, the testing will likely be useful in other clinical settings such as the primary care office (e.g. pediatrician), specialty care office (e.g. sports medicine), or emergency room to determine if an injured child requires additional intervention.
Detailed description
BACKGROUND
Head injuries are a frequent source of morbidity and the most common source of mortality in the pediatric trauma population. [1] It is estimated that head injuries result in more than 500,000 emergency department visits, 95,000 hospital admissions and 7,000 deaths in the pediatric age-groups. [1] Despite the magnitude of these numbers, they likely underestimate the problem, as many injured children are not brought to medical attention. Fortunately, most head injuries (75%) are classified as minor. [2] While major head injuries obviously pose a greater threat to life for the individual, the sheer volume of minor head injuries, as well as the potential for enduring neurologic sequelae, makes them a significant public health problem. Management of this large group of patients can be most challenging due to a lack of consensus in the health care community regarding the definition of minor traumatic brain injury, the ideal assessment modality for the injured child and recommendations for return to activity following a brain injury. Return to play recommendations have traditionally been based on the grade of concussion and the clinical exam. However given the large number of concussion grading scales in existence and the subtle nature of many of the neurologic deficits, standard recommendations have been lacking. Further still, the tremendous variability in time to full recovery exhibited by brain-injured children make generic guidelines naïve.
While the recovery from head injury in children is variable and difficult to predict, the desire to return to activity however, is near constant. Determining when it is safe to return to play is thus important. Recent literature has highlighted the perils of premature return to activities (most notably contact sports) for children with traumatic brain injury. [3-6] Dangers include prolongation of post-concussive symptoms, increased risk of recurrence of injury and death.[3-6] Further, these dangers may be more common in the younger athletes.[7] However, there is evidence that even non-contact, exertional activities may be detrimental if initiated too quickly. It was the observation of the First International Conference on Concussion in Sport that no previously published guidelines for management of concussion was adequate for assessment of all concussions. Further, they recognized the utility of neuropsychological testing in understanding the injury and determining management for the concussed patient. [8] Unfortunately, the majority of treating clinicians have few tools available to help determine when it is appropriate for the individual to return to activities. One such tool that has been used extensively and effectively in the head injured athlete is the Immediate Post concussion Assessment and Cognitive Testing (ImPACT©) program. This is an interactive software program originally designed to assess subjective and objective cognitive abilities of the head injured athlete. The program has been validated for use in sports-related concussion. [9, 10] Studies of concussed athletes have demonstrated a much slower return to baseline than previously had been appreciated. [11] Further, the younger athletes (high school vs. college or professional) were the slowest to return to the baseline. [7] This program has proven quite useful in determining the optimal time to return to activities in the population of head injured athletes by providing objective data upon which to base recommendations.
The same decisions facing clinicians treating children with sports related head injuries also exist for other non-sports related mechanisms (e.g. motor vehicle collisions, falls). Motor vehicle related causes and falls are the most common sources of traumatic brain injury in children. [12] Sports and recreation account for less than 10% of hospitalized minor traumatic brain injuries. Non-sports related traumatic brain injuries are often more severe but can be equally as difficult to assess. Anecdotal evidence collected by the researchers with the ImPACT© team suggests that the neurocognitive testing would be similarly efficacious in the assessment of non-sports related brain injured patients.
Utilizing a treatment algorithm that involves neurocognitive testing at the level of the individual is most likely to effectively determine the suitability to return to activities and the need for specialty intervention.
SPECIFIC AIMS
- To assess the feasibility of inpatient bedside neurocognitive testing of pediatric patients with minor traumatic brain injury.
- To establish if neurocognitive deficits exist, and to what extent, in the cohort of hospitalized pediatric patients with minor traumatic brain injury.
- To document the timing and extent of recovery for pediatric traumatic brain injury through follow-up neurocognitive testing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild Traumatic Brain Injury (MTBI) admits | – | Other: Immediate Post-concussion Assessment and Cognitive Testingadmitted pediatric patients with mild traumatic brain injury (concussion) |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric blunt trauma patients (age 11-19 years) admitted to The Children's Hospital of Philadelphia for treatment of mild traumatic brain injury
Key inclusion criteria (2 listed)
- Pediatric blunt trauma patients (age 11-19 years) admitted for treatment of minor traumatic brain injury will be eligible for inclusion in the study. For the purposes of this study, mild traumatic brain injury will include patients with a Glasgow Coma Scale (GCS) of 14-15 upon arrival in the trauma receiving area. This may include those patients with and without abnormalities on head CT scans.
- Children will be included regardless of race, gender or ethnicity. The distribution of gender, race, and ethnicity is expected to reflect that of the trauma population at The Children's Hospital of Philadelphia
Key exclusion criteria (1 listed)
- Patients with penetrating injuries as well as patients treated and released from the emergency room will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Post-concussion Assessment and Cognitive TestingImPACT© utilizes a battery of neurocognitive tests to assess neurologic deficits. | Other | Mild Traumatic Brain Injury (MTBI) admits |
Primary outcome
The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.
Time frame: Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.
In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).
1 secondary outcome
To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.
Time frame: study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19387313Nance ML, Polk-Williams A, Collins MW, Wiebe DJ. Neurocognitive evaluation of mild traumatic brain injury in the hospitalized pediatric population. Ann Surg. 2009 May;249(5):859-63. doi: 10.1097/SLA.0b013e3181a41ae5.
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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.
Michael L. Nance, MD principal investigator
Children's Hospital of Philadelphia
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 Mild Traumatic Brain Injury and Concussion, run by Children's Hospital of Philadelphia 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 2 inclusion and 1 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 4 May 2015. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury. (time frame: Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715949, which also lists 1 linked publication.
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 4 May 2015.