Health Outcomes for Acute Concussion (HOAC)

Kendra Jorgensen-Wagers

Status

Unknown

Conditions

Brain Injury, Acute

Treatments

Device: Brain Gauge Prospective and Healthy Control

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT04087434

N00014-18-C-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

300 participants in 3 patient groups

Retrospective

Description:

retrospective review of 300 records of patients following concussive diagnosis to track recovery and adherence to progressive return to activity recommendations.

Prospective

Description:

300 prospective patients enrolled following concussive diagnosis to track recovery, clinical diagnosis and brain gauge performance.

Treatment:

Device: Brain Gauge Prospective and Healthy Control

Control Group

Description:

75-100 Healthy Controls recruited by Fort Bragg to assess performance in a healthy population for brain gauge performance.

Treatment:

Device: Brain Gauge Prospective and Healthy Control