Multisite Randomized Controlled Trial of Targeted Multidomain (T-MD) Interventions for Complex mTBI
Abstract
During the past 19 years, U.S. military personnel experienced nearly 316,000 mild traumatic brain injuries (mTBI), with up to 95,000 being classified as complex (involving vestibular [dizziness, imbalance]), cognitive (memory, processing speed), somatosensory (vision, body position), and/or autonomic (heart rate, blood pressure) dysregulation. If untreated, these complex mTBIs result in chronic symptoms and impairment and long-term morbidity. However, treatments that target the involved domains can improve symptoms, reduce impairment, and accelerate return to activity or duty (RTA/D). In fact, we recently concluded a successful randomized controlled trial (RCT) study supporting the effectiveness of targeted vestibular rehabilitation exercises in civilians with complex mTBI. We are also currently conducting a Department of Defense-funded RCT to determine the best frequency and intensity of vestibular therapies in military personnel and civilians. However, treatments for complex mTBI do not typically occur in a vacuum. More often, treatments that target different domains, including anxiety/mood, autonomic, cognitive, migraine/headache, ocular, sleep, and vestibular, are warranted, as patients may experience multiple types of symptoms and impairment following complex mTBI. Although symptom and impairment specific treatments are commonly used by military medical personnel, there are no well-designed studies looking at how effective these targeted treatments are compared to standard behavioral management (rest/activity, hydration, nutrition, sleep, stress) interventions. In short, although targeted, multi-domain (T-MD) treatments are being implemented by military medical personnel following complex mTBI, we do not know whether they work and, if so, which ones are the most effective. Consequently, military medical personnel are left without clear, evidence-based guidelines for treating personnel with complex mTBI. In the proposed study, we will build on the empirical and clinical foundation of our previous work assessing and treating complex mTBI through our T-MD treatment approach. The objective of this 3-year multisite RCT is to determine the effectiveness of a T-MD (anxiety/mood, autonomic, cognitive, migraine, ocular, vestibular, sleep) compared to usual care (behavioral management) in military-aged civilians with complex mTBI. The proposed T-MD RCT will involve identifying complex mTBI domains or clinical profiles using specific symptoms, impairments, and functional limitations and prescribing targeted interventions to address each patient’s profile. We will leverage our 19+ years of experience in interdisciplinary mTBI care and research and access to ~10,500 combined patients annually at University of Pittsburgh (UPitt)/UPMC Sports Concussion Program and the Inova Concussion Program in Virginia to enroll 200 military aged civilians with complex mTBI within 1-6 months following injury. Participants will be randomly assigned to receive T-MD or usual care intervention. The T-MD group will receive targeted interventions (cognitive behavioral therapy, cognitive accommodations/activities, behavioral regulation, vestibular and oculomotor exercises, sleep intervention, graded exertion) for affected clinical profiles based on the adjudication process, whereas usual care will only receive behavioral management (rest/activity, hydration, nutrition, sleep, stress). In-clinic treatment will be complemented with at-home activities. Compliance will be monitored using a text-based tool we have used previously. We will assess outcomes at baseline, 2 weeks, 4 weeks, and 3 months. We will also assess return to activity (RTA) status at each visit and evaluate healthcare utilization costs. Determination of recovery or RTA/D following complex mTBI is a clinical decision that is based on observed and patient-reported indirect outcomes of brain function including symptoms, impairment, and response to exertion-based protocols.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010745
Entities
People
- Anthony Kontos
Organizations
- United States Army
- University of Pittsburgh