Brain Injury, AcuteHOACNCT04087434
Health Outcomes for Acute Concussion
An observational study of Brain Injury, Acute, run by Kendra Jorgensen-Wagers at 1 site in Germany.
Trial summary
The primary purpose of this prospective observational trial is to validate the Brain Gauge device as an objective tool for concussion assessment and treatment in order to determine if a method that has proven successful in 18-22 year old collegiate student-athletes will be applicable for military personnel. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Injury, Acute
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2018to 30 Jun 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Active duty service members with or without a concussion diagnosis within the past 7 days.
Who may be able to join
- Active duty military aged 18-60 stationed within local catchment area.
- Confirmed concussion within the last 72 hours
Who cannot join
- a sensory, motor or central neurological disorder such as seizures, ADD/ADHD, autism or neuropathy in the hands.
- Subtest test records incomplete for key variables such as symptom report inventories.
- Current MEB in process.
- Pregnant women as there are parts of the Clinical practice guide that cannot be implemented as a part of standard clinical care due to pregnancy.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Landstuhl Regional Medical Center
Landstuhl, Rhineland-Palatinate, 09180
Dawn M Collins, MA, 49637194645601, dawn.m.collins48.ctr@mail.mil
Anna M Komitov, MS, 94637194645601, anna.m.komitov.ctr@mail.mil
About this study
Official title: HOAC: Improving Health Outcomes for Acute Concussion Patients
The primary purpose of this prospective observational trial is to validate the Brain Gauge device as an objective tool for concussion assessment and treatment in order to determine if a method that has proven successful in 18-22 year old collegiate student-athletes will be applicable for military personnel. Overall aims of the study include:
- Demonstration that the Brain Gauge can objectively measure concussion in this population and thus improve concussion identification and coding.
- Demonstration of stronger screening for and tracking of acute concussion and documentation of concussion diagnoses, including improved tracking of recovery and greater adherence to DOD/VA Clinical Practice Guidelines for acute concussion.
Read the detailed description
The primary purpose of this prospective observational trial is to validate the Brain Gauge device as an objective tool for concussion assessment and treatment in order to determine if a method that has proven successful in 18-22 year old collegiate student-athletes will be applicable for military personnel. Overall aims of the study include: Demonstration that the Brain Gauge can objectively measure concussion in this population and thus improve concussion identification and coding; Demonstration of stronger screening for and tracking of acute concussion and documentation of concussion diagnoses, including improved tracking of recovery and greater adherence to DOD/VA Clinical Practice Guidelines for acute concussion.
A retrospective cohort of 300 anonymized patients from Landstuhl Regional Medical Center will be used as historical controls to assess diagnosis and recovery patterns, while a comparison cohort of 100 healthy active duty members from Fort Bragg, NC, will be used as uninjured controls to establish baseline Brain Gauge metrics in this population.
For the prospective cohort, all participants will receive comprehensive standard of care medical assessment and treatment as determined by their clinical team and as appropriate to their injury and course of recovery. In addition to standard assessments, participants will complete the Brain Gauge assessments at home or in the clinic at selected time points from initial assessment through 90 days post-study entry. The Brain Gauge system is designed for use by the patient at home and is easily incorporated in a remote, tele-health based patient monitoring system.
Data will be analyzed for compliance with current military Clinical Practice Guidelines (CPGs) for mTBI, both with the use of the Brain Gauge system and prior to its implementation. Objective cortical neurofunctional measures from the Brain Gauge instrument will be compared to standardized clinical measures.
- Conditions
- Brain Injury, Acute
- Being tested
- Brain Gauge Prospective and Healthy Control
- Keywords
- concussion
- Medical subject headings
- Brain Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Gauge Prospective and Healthy ControlDevice
The Brain Gauge is a brain health assessment system that takes advantage of the well-documented relationship between the sensory nerves in the fingers and the projection of those nerves to corresponding regions in the brain. The system is composed of a test device (the Brain Gauge) that uses novel fingertip vibration patterns to probe cortical complexity and utilize that complexity to gain more sensitive and specific detection of compromised neural function.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | retrospective review of 300 records of patients following concussive diagnosis to track recovery and adherence to progressive return to activity recommendations. | |
| Prospective | 300 prospective patients enrolled following concussive diagnosis to track recovery, clinical diagnosis and brain gauge performance. Receives: Device: Brain Gauge Prospective and Healthy Control | |
| Control Group | 75-100 Healthy Controls recruited by Fort Bragg to assess performance in a healthy population for brain gauge performance. Receives: Device: Brain Gauge Prospective and Healthy Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate Brain Gauge to detect clinical/ statistically significant change in reaction time, reaction time variability, temporal order judgment, accuracy,fatigue and stimulus discrimination between concussed and healthy controls..
The Brain Gauge is a health assessment system that takes advantage of the relationship between the sensory nerves in the fingers and the projection of those nerves to the corresponding regions in the brain. The system is composed of a mouse sized test device that uses novel fingertip vibration patterns to probe cortical connectivity and utilize that connectivity to gain more sensitive and specific detection of neural function. In sports concussion studies using this technology has established efficacy for detecting mild traumatic brain injury and tracking its recovery for differentiating individuals with and without traumatic brain injury with no baseline measures required.
Measured: 90 days
Secondary outcomes (1)
Examine utility of remote telehealth clinical oversight for TBI recovery to improve accountability, and responsibilities for tracking concussion recovery
Prove efficacy of assessment via remote capability with synchronous and asynchronous Telehealth clinical oversight from TBI trained staff. This trial utilizes a symptom tracking application that patients can deploy on their own phones and complete the neurobehavioral symptom inventory. Mild traumatic brain injuries are difficult to diagnose or assess and are particularly difficult to assess in circumstances were triage decisions are necessary. Use of the Brain Gauge device as well as a patient centered commercial off the shelf software is hypothesized to not only increase patient compliance in treatment but also significantly personalize treatment to foster stronger recovery.
Measured: over the course of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start18 Jun 2018
- Primary completion10 Jan 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kendra Jorgensen-Wagers
- Sponsor type
- US federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center
- Responsible party
- Sponsor-investigator, Kendra Jorgensen-Wagers, Office of Naval Research (ONR)
- Investigators
- Kendra L Jorgensen-Wagers, Ph.D, Principal investigator, The Defense and Veterans Brain Injury Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087434
- Sponsor's protocol ID
- N00014-18-C-2019
- Acronym
- HOAC
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOAC: Improving Health Outcomes for Acute Concussion Patients
- ClinicalTrials.gov ID
- NCT04087434
- Acronym / sponsor ID
- HOAC / N00014-18-C-2019
- Conditions
- Brain Injury, Acute
- Keywords
- concussion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kendra Jorgensen-WagersUS federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 10 Jan 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 12 Sep 2019 (actual)
- 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 primary purpose of this prospective observational trial is to validate the Brain Gauge device as an objective tool for concussion assessment and treatment in order to determine if a method that has proven successful in 18-22 year old collegiate student-athletes will be applicable for military personnel. Overall aims of the study include:
- Demonstration that the Brain Gauge can objectively measure concussion in this population and thus improve concussion identification and coding.
- Demonstration of stronger screening for and tracking of acute concussion and documentation of concussion diagnoses, including improved tracking of recovery and greater adherence to DOD/VA Clinical Practice Guidelines for acute concussion.
Detailed description
The primary purpose of this prospective observational trial is to validate the Brain Gauge device as an objective tool for concussion assessment and treatment in order to determine if a method that has proven successful in 18-22 year old collegiate student-athletes will be applicable for military personnel. Overall aims of the study include: Demonstration that the Brain Gauge can objectively measure concussion in this population and thus improve concussion identification and coding; Demonstration of stronger screening for and tracking of acute concussion and documentation of concussion diagnoses, including improved tracking of recovery and greater adherence to DOD/VA Clinical Practice Guidelines for acute concussion.
A retrospective cohort of 300 anonymized patients from Landstuhl Regional Medical Center will be used as historical controls to assess diagnosis and recovery patterns, while a comparison cohort of 100 healthy active duty members from Fort Bragg, NC, will be used as uninjured controls to establish baseline Brain Gauge metrics in this population.
For the prospective cohort, all participants will receive comprehensive standard of care medical assessment and treatment as determined by their clinical team and as appropriate to their injury and course of recovery. In addition to standard assessments, participants will complete the Brain Gauge assessments at home or in the clinic at selected time points from initial assessment through 90 days post-study entry. The Brain Gauge system is designed for use by the patient at home and is easily incorporated in a remote, tele-health based patient monitoring system.
Data will be analyzed for compliance with current military Clinical Practice Guidelines (CPGs) for mTBI, both with the use of the Brain Gauge system and prior to its implementation. Objective cortical neurofunctional measures from the Brain Gauge instrument will be compared to standardized clinical measures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –retrospective review of 300 records of patients following concussive diagnosis to track recovery and adherence to progressive return to activity recommendations. |
| Prospective | – | Device: Brain Gauge Prospective and Healthy Control300 prospective patients enrolled following concussive diagnosis to track recovery, clinical diagnosis and brain gauge performance. |
| Control Group | – | Device: Brain Gauge Prospective and Healthy Control75-100 Healthy Controls recruited by Fort Bragg to assess performance in a healthy population for brain gauge performance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Active duty service members with or without a concussion diagnosis within the past 7 days.
Key inclusion criteria (2 listed)
- Active duty military aged 18-60 stationed within local catchment area.
- Confirmed concussion within the last 72 hours
Key exclusion criteria (4 listed)
- a sensory, motor or central neurological disorder such as seizures, ADD/ADHD, autism or neuropathy in the hands.
- Subtest test records incomplete for key variables such as symptom report inventories.
- Current MEB in process.
- Pregnant women as there are parts of the Clinical practice guide that cannot be implemented as a part of standard clinical care due to pregnancy.
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 |
|---|---|---|
| Brain Gauge Prospective and Healthy ControlThe Brain Gauge is a brain health assessment system that takes advantage of the well-documented relationship between the sensory nerves in the fingers and the projection of those nerves to corresponding regions in the brain. The system is composed of a test device (the Brain Gauge) that uses novel fingertip vibration patterns to probe cortical complexity and utilize that complexity to gain more sensitive and specific detection of compromised neural function. | Device | Control Group, Prospective |
Primary outcome
Validate Brain Gauge to detect clinical/ statistically significant change in reaction time, reaction time variability, temporal order judgment, accuracy,fatigue and stimulus discrimination between concussed and healthy controls..
Time frame: 90 days
The Brain Gauge is a health assessment system that takes advantage of the relationship between the sensory nerves in the fingers and the projection of those nerves to the corresponding regions in the brain. The system is composed of a mouse sized test device that uses novel fingertip vibration patterns to probe cortical connectivity and utilize that connectivity to gain more sensitive and specific detection of neural function. In sports concussion studies using this technology has established efficacy for detecting mild traumatic brain injury and tracking its recovery for differentiating individuals with and without traumatic brain injury with no baseline measures required.
1 secondary outcome
Examine utility of remote telehealth clinical oversight for TBI recovery to improve accountability, and responsibilities for tracking concussion recovery
Time frame: over the course of a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Kendra L Jorgensen-Wagers, Ph.D principal investigator
The Defense and Veterans Brain Injury Center
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 Brain Injury, Acute, run by Kendra Jorgensen-Wagers at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 12 Sep 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kendra L Jorgensen-Wagers, Ph.D. (+49637194644995, kendra.l.jorgensen-wagers.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate Brain Gauge to detect clinical/ statistically significant change in reaction time, reaction time variability, temporal order judgment, accuracy,fatigue and stimulus discrimination between concussed and healthy controls.. (time frame: 90 days). 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 12 Sep 2019.