Brain Injury, Acute Clinical Trial
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:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03004976 -
Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke
|
Phase 2 |