Clinical Research Directory

Positive Assurance and mTBI

This study will develop and validate a new educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

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.

Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.

Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)

The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the acute period after concussion. Secondary objectives include documenting symptom severity (ANS related symptoms, post-concussion symptoms, anxiety, sleep) before and after administration of the intervention and examine whether early paced-breathing exercise can accelerate recovery and symptom improvement. Participants will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment, information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.

Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use

The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs. Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.