Clinical trial NCT04087434: Health Outcomes for Acute Concussion
Official title: HOAC: Improving Health Outcomes for Acute Concussion Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injury, Acute
Keywords: concussion
Lead sponsor: Office of Naval Research (ONR)
Sponsor class: FED
Collaborators: name: The Defense and Veterans Brain Injury Center
First posted: 2019-09-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty service members with or without a concussion diagnosis within the past 7 days.

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.

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.

Eligibility 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.

Primary outcomes:
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..
timeFrame: 90 days
Secondary outcomes:
measure: Examine utility of remote telehealth clinical oversight for TBI recovery to improve accountability, and responsibilities for tracking concussion recovery
timeFrame: over the course of a year
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
state: Rheinland Pfalz
Study officials:
affiliation: The Defense and Veterans Brain Injury Center
name: Kendra L Jorgensen-Wagers, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: