Health Outcomes for Acute Concussion
HOAC
HOAC: Improving Health Outcomes for Acute Concussion Patients
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2018
CompletedFirst Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedSeptember 12, 2019
September 1, 2019
1.6 years
April 23, 2019
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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..
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.
90 days
Secondary Outcomes (1)
Examine utility of remote telehealth clinical oversight for TBI recovery to improve accountability, and responsibilities for tracking concussion recovery
over the course of a year
Study Arms (3)
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.
Control Group
75-100 Healthy Controls recruited by Fort Bragg to assess performance in a healthy population for brain gauge performance.
Interventions
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.
Eligibility Criteria
Active duty service members with or without a concussion diagnosis within the past 7 days.
You may qualify if:
- Active duty military aged 18-60 stationed within local catchment area.
- Confirmed concussion within the last 72 hours
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Landstuhl Regional Medical Center
Landstuhl, Rhineland-Palatinate, 09180, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kendra L Jorgensen-Wagers, Ph.D
The Defense and Veterans Brain Injury Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Clinical Research Director
Study Record Dates
First Submitted
April 23, 2019
First Posted
September 12, 2019
Study Start
June 18, 2018
Primary Completion
January 10, 2020
Study Completion
June 30, 2020
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share