Brain ConcussionMTBIDNCT02453958
Mild Traumatic Brain Injury Discrimination
A study testing Multi-modal assessment system in people with Brain Concussion, run by Empirical Technologies Corporation.
Trial summary
Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Multi-modal assessment system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jan 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Military personnel
- Age 18 to 45
- Diagnosis of mTBI within past 5 years
- Rancho Los Amigos Scale score of 7 or above
Who cannot join
- Non-military individuals
- Below age 18 or older than 45
- No diagnosis of mTBI within past 5 years
- Rancho Los Amigos Scale score of 6 or below
About this study
Official title: Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury
Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.
Read the detailed description
This was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. These results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. This represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.
- Conditions
- Brain Concussion
- Being tested
- Multi-modal assessment system
- Keywords
- Injury, Brain, Traumatic Mild, Mild Traumatic Brain Injury
- Medical subject headings
- Brain Concussion, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal assessment systemDevice
Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests
| Study group | Role | What they receive |
|---|---|---|
| mTBI-diagnosed group | Experimental | Subjects diagnosed with mTBI were assessed with a multi-modal assessment system. Receives: Device: Multi-modal assessment system |
| non mTBI-diagnosed group | Experimental | Non-concussed subjects were assessed with a multi-modal assessment system. Receives: Device: Multi-modal assessment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receiver-operator-curve area under the curve (AUC)
Each test's discrimination capability was quantified using AUC and p value
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionJan 2013
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empirical Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunter Holmes Mcguire Veteran Affairs Medical Center, Walter Reed Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Martin C. Baruch, PhD, Principal investigator, Empirical Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453958
- Sponsor's protocol ID
- ETC_mTBI_001
- Acronym
- MTBID
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02453958
- Acronym / sponsor ID
- MTBID / ETC_mTBI_001
- Conditions
- Brain Concussion
- Keywords
- Injury, Brain, Traumatic Mild, Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Empirical Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Hunter Holmes Mcguire Veteran Affairs Medical Center, Walter Reed Army Medical Center
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 May 2015 (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.
Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.
Detailed description
This was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. These results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. This represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTBI-diagnosed group | Experimental | Device: Multi-modal assessment systemSubjects diagnosed with mTBI were assessed with a multi-modal assessment system. |
| non mTBI-diagnosed group | Experimental | Device: Multi-modal assessment systemNon-concussed subjects were assessed with a multi-modal assessment system. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Military personnel
- Age 18 to 45
- Diagnosis of mTBI within past 5 years
- Rancho Los Amigos Scale score of 7 or above
Key exclusion criteria (4 listed)
- Non-military individuals
- Below age 18 or older than 45
- No diagnosis of mTBI within past 5 years
- Rancho Los Amigos Scale score of 6 or below
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 |
|---|---|---|
| Multi-modal assessment systemSubjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests | Device | mTBI-diagnosed group, non mTBI-diagnosed group |
Primary outcome
Receiver-operator-curve area under the curve (AUC)
Time frame: up to 5 years
Each test's discrimination capability was quantified using AUC and p value
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 27 May 2015.
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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.
Martin C. Baruch, PhD principal investigator
Empirical Technologies Corporation
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal assessment system in people with Brain Concussion, run by Empirical Technologies Corporation.
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 4 inclusion and 4 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Receiver-operator-curve area under the curve (AUC) (time frame: up to 5 years). 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 27 May 2015.