Topics

Health Outcomes for Acute Concussion

2019-09-18 03:27:50 | BioPortfolio

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.

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.

Study Design

Conditions

Brain Injury, Acute

Intervention

Brain Gauge Prospective and Healthy Control

Location

Landstuhl Regional Medical Center
Landstuhl
Rheinland Pfalz
Germany
09180

Status

Recruiting

Source

Office of Naval Research (ONR)

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:50-0400

Clinical Trials [7777 Associated Clinical Trials listed on BioPortfolio]

Traumatic Brain Injury and Effects of Acute Cyclosporine A

This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for other...

Monitoring Brain Activity in Human Brain Injury

The outcome of brain injury (physical or stroke) may be related to a brain electrical phenomenon known as Cortical Spreading Depression (CSD). This is a brief cessation of function in a l...

Outcome Predictors in Acute Brain Injury

This study will attempt to evaluate clinical, laboratory and radiographic parameters together to assess heir values in outcome prediction from brain injury. Patients will be followed up fo...

Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)

This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aS...

Brain Injury Inpatient Educational Intervention for Families and Caregivers

The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive intervention to meet the needs of family members and significant others of patients who are unde...

PubMed Articles [30054 Associated PubMed Articles listed on BioPortfolio]

Detection of Brain Activation in Unresponsive Patients with Acute Brain Injury.

Brain activation in response to spoken motor commands can be detected by electroencephalography (EEG) in clinically unresponsive patients. The prevalence and prognostic importance of a dissociation be...

Stomaching Acute Brain Injury.

Gastrointestinal complications, including hemorrhage, can occur with intracranial lesions and after craniotomy. As early as the 19th century, surgeons were aware that brain tumors could cause gastric ...

Deployment, suicide, and overdose among comorbidity phenotypes following mild traumatic brain injury: A retrospective cohort study from the Chronic Effects of Neurotrauma Consortium.

Mild traumatic brain injury in the Veteran population is frequently comorbid with pain, post-traumatic stress disorder, and/or depression. However, not everyone exposed to mild traumatic brain injury ...

MRI Brain Changes After Marathon Running: Results of the Berlin Beat of Running Study.

Several studies report neurological complications such as brain injury induced by ischemia or edema following exhaustive endurance sport. We aimed to detect the frequency of acute brain lesions after ...

Concomitant chest trauma and traumatic brain injury, biomarkers correlate with worse outcomes.

Clinical data are lacking on the influence of chest trauma on the secondary injury process after traumatic brain injury (TBI), with some data suggesting that multiple trauma may worsens brain injury. ...

Medical and Biotech [MESH] Definitions

Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.

Prolonged unconsciousness from which the individual cannot be aroused, associated with traumatic injuries to the BRAIN. This may be defined as unconsciousness persisting for 6 hours or longer. Coma results from injury to both cerebral hemispheres or the RETICULAR FORMATION of the BRAIN STEM. Contributing mechanisms include DIFFUSE AXONAL INJURY and BRAIN EDEMA. (From J Neurotrauma 1997 Oct;14(10):699-713)

A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain.

A technique to self-regulate brain activities provided as a feedback in order to better control or enhance one's own performance, control or function. This is done by trying to bring brain activities into a range associated with a desired brain function or status.

Conditions characterized by persistent brain damage or dysfunction as sequelae of cranial trauma. This disorder may result from DIFFUSE AXONAL INJURY; INTRACRANIAL HEMORRHAGES; BRAIN EDEMA; and other conditions. Clinical features may include DEMENTIA; focal neurologic deficits; PERSISTENT VEGETATIVE STATE; AKINETIC MUTISM; or COMA.

More From BioPortfolio on "Health Outcomes for Acute Concussion"

Quick Search

Searches Linking to this Trial