Traumatic Brain InjuryNCT01728142
Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion
A study testing DANA Brief and ANAM in people with Traumatic Brain Injury and Brain Concussion, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in Afghanistan.
Trial summary
The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable, portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological Assessment Metrics (ANAM) battery currently… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Brain Concussion
- What is being tested?
- DANA Brief and ANAM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteAfghanistan
- Study dates
- Jan 2013to Aug 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 U.S. military service members
- Clinical diagnosis of concussion/mild traumatic brain injury (mTBI) (as defined by the American Congress of Rehabilitation, 1993, and DoD), made by the treating clinician based on clinical history, examination and/or clinical imaging performed as part of standard of care. This includes subjects with concussion from any mechanism (blast-related, blunt trauma etc.)--for concussed subjects only
- Glasgow Coma Scale (GCS) score of 15 as assessed by the consenting research staff--for concussed subjects only
- Concussive event that occurred within 72 hours of injury (to exclude service members presenting due to lingering effects of a previous injury)--for concussed subjects only
- Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent.
Who cannot join
- Have a history of other mTBI within 90 days, moderate brain injury within the past 3 years, or any lifetime history of severe brain injury
- History of a documented diagnosis of post traumatic stress disorder (PTSD) or of treatment for PTSD
- Taking psychoactive medications, opioids, or other significant sedating medication
- Individuals with severe psychiatric disorders requiring continuing medication or recent treatment for an alcohol or drug dependency
- Report a pain level of 8 or greater on the 10-point Likert scale of 1 to 10 (e.g., 8, 9 or 10).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Brief Exam to the Automated Neuropsychological Assessment Metrics (ANAM) Battery in the Evaluation of Cognitive Changes During Concussion Recovery
The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable, portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological Assessment Metrics (ANAM) battery currently used by the military after concussion. The primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued impaired cognitive performance than the ANAM during recovery after a concussion.
Read the detailed description
Among active duty military personnel deployed to combat theaters, blast injury is a leading cause of traumatic brain injury (TBI). Service members with TBI can experience notable neurological impairments-e.g., attention disturbances, memory and language deficits, and delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion with no overt physical symptoms. Thus, there is a critical need to have an efficient means to determine the incidence of cognitive deficits in service members exposed to or injured by blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which neurocognitive test more reliably and accurately detects cognitive impairments during the recovery period from a concussion.
- Conditions
- Traumatic Brain Injury, Brain Concussion
- Being tested
- DANA Brief, ANAM
- Keywords
- DANA, ANAM, Concussion, mild traumatic brain 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.
DANA BriefDevice
The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.
ANAMOther
The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
| Study group | Role | What they receive |
|---|---|---|
| Non-concussed | Active comparator | Control group; individuals assigned to this group will be either healthy volunteers or individuals sustaining an injury that does not involve concussion. Participants will take both the ANAM and DANA Brief twice at minimum. Receives: Device: DANA Brief; Other: ANAM |
| Concussed | Experimental | Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum. Receives: Device: DANA Brief; Other: ANAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of DANA Brief's improved sensitivity compared to ANAM
Outcome will be confirmed by the ability of the DANA Brief to detect statistically significant differences in cognitive performance between concussed and non-concussed groups even after the ANAM has indicated full recovery
Measured: within 10 days of 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 completionAug 2014
- Study completionAug 2014
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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 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 Tsao, MD, DPhil, Principal investigator, U.S. Navy Bureau of Medicine and Surgery (BUMED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728142
- Sponsor's protocol ID
- M-10244
- Status last verified
- Oct 2017
- First submitted
- 13 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) Brief Exam to the Automated Neuropsychological Assessment Metrics (ANAM) Battery in the Evaluation of Cognitive Changes During Concussion Recovery
- ClinicalTrials.gov ID
- NCT01728142
- Acronym / sponsor ID
- M-10244
- Conditions
- Traumatic Brain Injury, Brain Concussion
- Keywords
- DANA, ANAM, Concussion, mild traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 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
- Aug 2014 (actual)
- Study completion
- Aug 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 Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable, portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological Assessment Metrics (ANAM) battery currently used by the military after concussion. The primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued impaired cognitive performance than the ANAM during recovery after a concussion.
Detailed description
Among active duty military personnel deployed to combat theaters, blast injury is a leading cause of traumatic brain injury (TBI). Service members with TBI can experience notable neurological impairments-e.g., attention disturbances, memory and language deficits, and delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion with no overt physical symptoms. Thus, there is a critical need to have an efficient means to determine the incidence of cognitive deficits in service members exposed to or injured by blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which neurocognitive test more reliably and accurately detects cognitive impairments during the recovery period from a concussion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-concussed | Active comparator | Device: DANA Brief, Other: ANAMControl group; individuals assigned to this group will be either healthy volunteers or individuals sustaining an injury that does not involve concussion. Participants will take both the ANAM and DANA Brief twice at minimum. |
| Concussed | Experimental | Device: DANA Brief, Other: ANAMIndividuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Active-duty U.S. military service members
- Clinical diagnosis of concussion/mild traumatic brain injury (mTBI) (as defined by the American Congress of Rehabilitation, 1993, and DoD), made by the treating clinician based on clinical history, examination and/or clinical imaging performed as part of standard of care. This includes subjects with concussion from any mechanism (blast-related, blunt trauma etc.)--for concussed subjects only
- Glasgow Coma Scale (GCS) score of 15 as assessed by the consenting research staff--for concussed subjects only
- Concussive event that occurred within 72 hours of injury (to exclude service members presenting due to lingering effects of a previous injury)--for concussed subjects only
- Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent.
Key exclusion criteria (5 listed)
- Have a history of other mTBI within 90 days, moderate brain injury within the past 3 years, or any lifetime history of severe brain injury
- History of a documented diagnosis of post traumatic stress disorder (PTSD) or of treatment for PTSD
- Taking psychoactive medications, opioids, or other significant sedating medication
- Individuals with severe psychiatric disorders requiring continuing medication or recent treatment for an alcohol or drug dependency
- Report a pain level of 8 or greater on the 10-point Likert scale of 1 to 10 (e.g., 8, 9 or 10).
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 BriefThe DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia. | Device | Concussed, Non-concussed |
| ANAMThe ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion. | Other | Concussed, Non-concussed |
Primary outcome
Evidence of DANA Brief's improved sensitivity compared to ANAM
Time frame: within 10 days of injury
Outcome will be confirmed by the ability of the DANA Brief to detect statistically significant differences in cognitive performance between concussed and non-concussed groups even after the ANAM has indicated full recovery
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 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 Brief and ANAM in people with Traumatic Brain Injury and Brain Concussion, 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 5 inclusion and 5 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?
Evidence of DANA Brief's improved sensitivity compared to ANAM (time frame: within 10 days of 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.