Brain ConcussionNCT01728129
DANA Compared to MACE in Evaluation of Suspected Acute Concussion
A study testing DANA Rapid and MACE in people with Brain Concussion and Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in Afghanistan.
Trial summary
The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive for detecting impaired cognitive performance than the MACE cognitive score in the setting of a clinical diagnosis of concussion at the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Traumatic Brain Injury
- What is being tested?
- DANA Rapid and MACE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAfghanistan
- Study dates
- Jan 2013to Nov 2014
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active duty military personnel
- Glasgow Coma Scale (GCS)score of 15, as assessed by the study member at the time of clinical evaluation following involvement in a mandatory event.
- Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent
Who cannot join
- GCS score of less than 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Tool to the Military Acute Concussion Evaluation (MACE) in the Evaluation of Suspected Acute Concussion
The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive for detecting impaired cognitive performance than the MACE cognitive score in the setting of a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary purpose of this study is to examine a serial performance on the DANA Rapid exam in those subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam will show improvements in performance during the recovery period after concussion.
Read the detailed description
In Operations Iraqi Freedom and Enduring Freedom (OIF/OEF), over 60% of combat casualties have been the result of explosive blasts, and many of these critical injuries involve trauma to the head. As a result, traumatic brain injury (TBI) has been deemed a "signature wound" of OIF and OEF. The symptoms of head injuries, particularly of concussion/mild TBI (mTBI), can be sever but subtle, suggesting that early and accurate diagnosis is paramount to a wounded warrior's appropriate medical care. Most first providers in the war theater are medics who could benefit from an improved diagnostic test to better identify service members with concussion/mTBI. The MACE cognitive test is heavily weighted towards memory, is not 100% specific, and does not preclude a diagnosis of concussion being rendered despite a score in the normal range. Thus, an objective test of neurocognitive function, such as the DANA Rapid, that can be rapidly administered in theater by a combat medic would be highly beneficial to accurate clinical diagnosis and timely treatment. The results of the present study will provide information on the predictive value of the newly developed DANA handheld computer in assisting in the diagnosis of concussion in service members who have been blast exposed. If the DANA Rapid exam proves to be equally or more accurate than the MACE in detecting cognitive deficits, these tests and the handheld computer will also contribute to improved health care for service members by minimizing the time between injury and diagnosis.
- Conditions
- Brain Concussion, Traumatic Brain Injury
- Being tested
- DANA Rapid, MACE
- Keywords
- Concussion, Mild traumatic brain injury, DANA, MACE
- 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.
DANA RapidDevice
The DANA Rapid is a neurocognitive test self-administered on a small handheld computer. The DANA Rapid subtests measure simple reaction time, procedural reaction time, and reaction time sensitivity.
MACEOther
The MACE is currently the only standardized and Department of Defense-designated method for the initial evaluation of suspected concussion in military operational settings. The MACE documents the history of the injury-causing incident; assesses cognitive deficits in orientation, immediate memory, concentration, and delayed recalls; and involves a neurological screening by a clinician.
| Study group | Role | What they receive |
|---|---|---|
| Concussed | Experimental | Subjects who are diagnosed with a concussion by a clinician will be assessed with the MACE and DANA Rapid every 24 hours for up to 72 hours post-injury. Receives: Device: DANA Rapid; Other: MACE |
| Non-concussed | Active comparator | Subjects will have been exposed to a potentially concussive event but be clinically evaluated and found not to have sustained a concussion. Control subjects from this arm will take both the MACE and DANA Rapid twice: once within 24 hours of potentially concussive event, and again on the day of return to duty. Receives: Device: DANA Rapid; Other: MACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The primary hypothesis is that an abnormal score on the DANA Rapid will positively identify a greater proportion of concussed individuals than an abnormal cognitive score on the MACE would. Conversely, scores within normal range on the DANA Rapid should be able to rule out cognitive deficits more accurately than a normal score on the MACE
Measured: 72 hours from initial injury
Secondary outcomes (1)
Serial Performance
The secondary hypothesis of the study is that scores on the DANA Rapid exam will improve over time as the subject recovers from concussion.
Measured: 72 hours from initial injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, jack tsao, United States Department of Defense
- Investigators
- Jack W. Tsao, MD, DPhil, Principal investigator, U.S. Navy Bureau of Medicine and Surgery (BUMED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728129
- Sponsor's protocol ID
- M-10228
- Status last verified
- Oct 2017
- First submitted
- 8 Nov 2012
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Tool to the Military Acute Concussion Evaluation (MACE) in the Evaluation of Suspected Acute Concussion
- ClinicalTrials.gov ID
- NCT01728129
- Acronym / sponsor ID
- M-10228
- Conditions
- Brain Concussion, Traumatic Brain Injury
- Keywords
- Concussion, Mild traumatic brain injury, DANA, MACE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Nov 2012 (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.
The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive for detecting impaired cognitive performance than the MACE cognitive score in the setting of a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary purpose of this study is to examine a serial performance on the DANA Rapid exam in those subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam will show improvements in performance during the recovery period after concussion.
Detailed description
In Operations Iraqi Freedom and Enduring Freedom (OIF/OEF), over 60% of combat casualties have been the result of explosive blasts, and many of these critical injuries involve trauma to the head. As a result, traumatic brain injury (TBI) has been deemed a "signature wound" of OIF and OEF. The symptoms of head injuries, particularly of concussion/mild TBI (mTBI), can be sever but subtle, suggesting that early and accurate diagnosis is paramount to a wounded warrior's appropriate medical care. Most first providers in the war theater are medics who could benefit from an improved diagnostic test to better identify service members with concussion/mTBI. The MACE cognitive test is heavily weighted towards memory, is not 100% specific, and does not preclude a diagnosis of concussion being rendered despite a score in the normal range. Thus, an objective test of neurocognitive function, such as the DANA Rapid, that can be rapidly administered in theater by a combat medic would be highly beneficial to accurate clinical diagnosis and timely treatment. The results of the present study will provide information on the predictive value of the newly developed DANA handheld computer in assisting in the diagnosis of concussion in service members who have been blast exposed. If the DANA Rapid exam proves to be equally or more accurate than the MACE in detecting cognitive deficits, these tests and the handheld computer will also contribute to improved health care for service members by minimizing the time between injury and diagnosis.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed | Experimental | Device: DANA Rapid, Other: MACESubjects who are diagnosed with a concussion by a clinician will be assessed with the MACE and DANA Rapid every 24 hours for up to 72 hours post-injury. |
| Non-concussed | Active comparator | Device: DANA Rapid, Other: MACESubjects will have been exposed to a potentially concussive event but be clinically evaluated and found not to have sustained a concussion. Control subjects from this arm will take both the MACE and DANA Rapid twice: once within 24 hours of potentially concussive event, and again on the day of return to duty. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active duty military personnel
- Glasgow Coma Scale (GCS)score of 15, as assessed by the study member at the time of clinical evaluation following involvement in a mandatory event.
- Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent
Key exclusion criteria (1 listed)
- GCS score of less than 15
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 |
|---|---|---|
| DANA RapidThe DANA Rapid is a neurocognitive test self-administered on a small handheld computer. The DANA Rapid subtests measure simple reaction time, procedural reaction time, and reaction time sensitivity. | Device | Concussed, Non-concussed |
| MACEThe MACE is currently the only standardized and Department of Defense-designated method for the initial evaluation of suspected concussion in military operational settings. The MACE documents the history of the injury-causing incident; assesses cognitive deficits in orientation, immediate memory, concentration, and delayed recalls; and involves a neurological screening by a clinician. | Other | Concussed, Non-concussed |
Primary outcome
Sensitivity
Time frame: 72 hours from initial injury
The primary hypothesis is that an abnormal score on the DANA Rapid will positively identify a greater proportion of concussed individuals than an abnormal cognitive score on the MACE would. Conversely, scores within normal range on the DANA Rapid should be able to rule out cognitive deficits more accurately than a normal score on the MACE
1 secondary outcome
Serial Performance
Time frame: 72 hours from initial 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 6 Oct 2017.
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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.
Jack W. Tsao, MD, DPhil principal investigator
U.S. Navy Bureau of Medicine and Surgery (BUMED)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DANA Rapid and MACE in people with Brain Concussion and Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in Afghanistan.
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 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 6 Oct 2017. 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 Afghanistan. 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?
Sensitivity (time frame: 72 hours from initial injury). 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 6 Oct 2017.