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Health Outcomes for Acute Concussion (HOAC)

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ClinicalTrials.gov Identifier: NCT04087434
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
Kendra Jorgensen-Wagers, Office of Naval Research (ONR)

Brief 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. Overall aims of the study include:

  1. Demonstration that the Brain Gauge can objectively measure concussion in this population and thus improve concussion identification and coding.
  2. 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.

Condition or disease Intervention/treatment
Brain Injury, Acute Device: Brain Gauge Prospective and Healthy Control

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: HOAC: Improving Health Outcomes for Acute Concussion Patients
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
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.
Device: Brain Gauge Prospective and Healthy Control
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.

Control Group
75-100 Healthy Controls recruited by Fort Bragg to assess performance in a healthy population for brain gauge performance.
Device: Brain Gauge Prospective and Healthy Control
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Active duty service members with or without a concussion diagnosis within the past 7 days.
Criteria

Inclusion Criteria

  • Active duty military aged 18-60 stationed within local catchment area.
  • Confirmed concussion within the last 72 hours

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087434


Contacts
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Contact: Kendra L Jorgensen-Wagers, Ph.D. +49637194644995 kendra.l.jorgensen-wagers.ctr@mail.mil
Contact: Wesley R Cole, Ph.D. 9109077709 wesley.r.cole.civ@mail.mil

Locations
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Germany
Landstuhl Regional Medical Center Recruiting
Landstuhl, Rheinland Pfalz, Germany, 09180
Contact: Dawn M Collins, MA    49637194645601    dawn.m.collins48.ctr@mail.mil   
Contact: Anna M Komitov, MS    94637194645601    anna.m.komitov.ctr@mail.mil   
Sponsors and Collaborators
Kendra Jorgensen-Wagers
The Defense and Veterans Brain Injury Center
Investigators
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Principal Investigator: Kendra L Jorgensen-Wagers, Ph.D The Defense and Veterans Brain Injury Center

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Responsible Party: Kendra Jorgensen-Wagers, Senior Clinical Research Director, Office of Naval Research (ONR)
ClinicalTrials.gov Identifier: NCT04087434     History of Changes
Other Study ID Numbers: N00014-18-C-2019
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kendra Jorgensen-Wagers, Office of Naval Research (ONR):
concussion
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries