Clinical Research Directory

Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care

This work will address an important gap in physical therapy rehabilitation after concussion. Physical therapy usually focuses on how the brain processes sensory information such as inner ear and vision for balance rehabilitation, but our recent research shows that people with imbalance more often have a problem with how they can respond to imbalance (i.e., motor activation). While there are complex laboratory tools to test motor activation for balance, these tests are not practical for the clinic. The goal of this study is to create both an exercise intervention focused on motor activation after concussion and simple, but objective and instrumented (wearable sensors), clinical measures of motor activation. Objectives: This research study has three aims. 1) The investigators and study team will develop an exercise program to improve the problems with how one's body responds to imbalance (i.e., improve motor activation) after a concussion. The study team will use a Community Based Participatory Research (CBPR) approach by collaborating with a team of people with a broad range of experience related to concussion. The study team will form a Community Advisory Board (CAB) that will include patients who have had a concussion, healthcare professionals with expertise in concussion, and healthcare administrators. The CAB will contain people working in the military and civilians. 2) The investigators will compare our new motor-focused physical therapy intervention to the standard sensory focused balance intervention. The goal is to determine which intervention program is more effective in treating balance problems after a concussion. The investigators hypothesize that the motor-focused program will help patients more compared to the sensory program. 3) The investigators and study team will create and test several balance tests that can be used in the clinical without expensive research equipment to our standard research-based motor activation tests. This aim will allow the study team to determine if the clinical tests perform as well as the research-grade tests. To make the test useful to clinicians, the study team will use simpler technology like smart-phone applications, wearable sensors, and virtual reality goggles that are both affordable and practical for healthcare providers.

Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History

The goal of this randomized controlled trial is to determine if an interactive digital solution, Man Therapy, reduces indices of problematic anger in male military service members who screen positive for problematic anger. The man questions this study aims to answer are: * Does Man Therapy reduce indices of problematic anger? * Does Man Therapy reduce psychosocial correlates of anger? Researchers will also examine if the effects of those aims differ based on a participant's history of a mild TBI, the mechanism of a primary mild TBI, and/or the number of mild TBIs. Researchers will compare Man Therapy to a waitlist control. This will help determine if Man Therapy works better than no treatment. Participants will: * Complete a baseline survey * Be randomized to intervention or waitlist control * If randomized to intervention, participants will receive the intervention and complete a survey immediately after the intervention and at 1-, and 3-months following the intervention * If randomized to waitlist control, participants complete surveys at 1-, and 3-months and have the opportunity to complete the intervention following the 3-month survey

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.

Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)

Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment. Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.

Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study

This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary. The study seeks to answer two primary questions: 1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care. 2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI. To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.

A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).