Phase 2 Randomized, Placebo-Controlled Clinical Trial of Recombinant Human Growth Hormone (rhGH) During Rehabilitation From Traumatic Brain Injury

Traumatic brain injury (TBI) is a major cause of death and disability, but there are currently no therapies with proven efficacy for optimizing regeneration of repair during rehabilitation. Using standard stimulation tests, as many as 40–50% of survivors of severe TBI have deficiency of one or more pituitary hormones. Of these, the somatotropic axis is the most commonly affected, with Growth Hormone (GH) deficiency affecting ~20% of persons with severe TBI. Treatment with recombinant human Growth Hormone (rhGH) is generally effective in reversing the effects of acquired GH deficiency, but there is no evidence documenting functional or neurocognitive improvement after GH replacement in TBI patients. As a consequence, screening for GH deficiency and GH replacement when deficiency is found is not routinely performed as part of the rehabilitation of TBI survivors. Given that most of the recovery after TBI occurs within the first 6–12 months after injury and IGF-1 and GH are part of a coordinated restorative neurotrophic system, we hypothesized that patients will optimally benefit from GH therapy during the window of maximal neuroregenerative activity. We performed a Phase IIa, randomized, double-blind, placebo-controlled feasibility trial of recombinant human Growth Hormone (rhGH), starting at discharge from an inpatient rehabilitation unit, with follow up at 6 and 12 months. Our primary hypothesis was that treatment with rhGH in the subacute period would result in improved functional outcomes 6 months after injury. Our secondary hypothesis proposed that treatment with rhGH would increase IGF-1 levels and be well tolerated. Sixty-three subjects were randomized, and 40 completed the trial. At baseline, there was no correlation between IGF-1 levels and peak GH levels after L-arginine stimulation. IGF-1 levels increased after rhGH treatment, but it took longer than 1 month for levels to be higher than for placebo-treated patients. rhGH therapy was well-tolerated. The rhGH group was no different from placebo in the Disability Rating Scale, Glasgow Outcome Scale-Extended, or neuropsychological function. However, a trend toward greater improvement from baseline in Functional Independence Measure (FIM) was noted in the rhGH treated group. Future studies should include longer treatment periods, faster titration of rhGH, and larger sample sizes

Caregiver Characteristics of Adults with Acute Traumatic Brain Injury in the United States and Latin America

Objectives: To compare characteristics of caregivers of adults with acute traumatic brain injury (TBI) in the U.S. and Latin America (Mexico and Colombia). Design: Secondary data analysis of two cohorts. Cohort 1: English-speaking caregivers of adults with TBI in the U.S. (n = 80). Cohort 2: Spanish-speaking caregivers of adults with TBI in Mexico or Colombia (n = 109). Results: Similarities between the U.S. and Latin American caregiver groups, respectively, were: predominantly women (81.3%, 81.7%, respectively); spouses/domestic partners (45%, 31.2%); and motor vehicle accident (41.5%, 48.6%) followed by fall etiologies (40%, 21.1%). Differences between U.S. and Latin American caregivers were: age (49.5 years, 41.5 years, p < 0.001); employment status ((X-5(2) = 59.63, p < 0.001), full-time employment (63.7%, 25.7%), homemaker (2.5%, 31.2%), and retired (17.5%, 1.8%)); violence-related etiology (2.5%, 15.6%); and severity of depressive symptoms (M = 7.9, SD = 5.8; M = 5.8, SD = 5.7; p = 0.014). Conclusions: TBI caregivers in the U.S. were older and employed full-time or retired more often than those in Latin America. Violence-related etiology was nearly five times more common in Latin America, raising concerns for potential implications of post-traumatic stress and family adjustment after injury. Although both groups likely could use mental health support, this was particularly true of the U.S. cohort, maybe due to differential demographics, mechanisms of injury, or family and community support.Data collection was supported by NIDILRR (grant numbers: Kessler 90DPTB0003; NTX-TBIMS 90DPTB0013; JFK 90DPTB0014) and Grant #R21TW009746 from the Fogarty International Center of the National Institutes of Health and in part by the Department of Veterans Affairs. Additional support for coauthors was provided by NIDILRR (grant numbers: Spaulding/Harvard TBIMS: 90DPTB0011; TIRR 90DPTB0016)

Traumatic Brain Injury Healthcare Utilization: Examining the Impact of Race and Insurance

Background: Traumatic brain injury (TBI) is a condition which ranges from mild to severe severity that can result in death or permanent disability. The most recent statistics indicate that approximately 2.5 million cases of TBI were reported in 2010. Race and insurance status are predictors associated with poorer outcomes such as increased emergent healthcare utilization. However, little is known regarding the association of race and insurance status on healthcare utilization following TBI. Thus, the purpose of this project was to examine the presence of disparities when considering the interaction of race and insurance status on healthcare utilization among individuals with TBI at a local Level 1 Trauma Acute Care Facility within one year after onset of TBI. Methods: A retrospective cohort was used to examine 4,150 patients admitted to Baylor University Medical Center (BUMC) with a TBI between the dates of January 1st, 2003 and June 30th, 2014. The cohort of patients and demographic and injury information was retrieved from the BUMC trauma database. Then, this database was combined with the Dallas Fort Worth Hospital Council (DFWHC) Database to track subsequent hospital admissions data in the Dallas Fort Worth Metroplex. Poisson regression determined the association of the interaction of race/ethnicity plus insurance status and the number of emergency, emergency and inpatient, and total healthcare encounters adjusting for age, gender, length of stay at initial admission after onset of TBI, total charges at initial admission, cause of injury, Glasgow coma score, and discharge status. Results: Patients were primarily male (64.5%), Caucasian (44.1%), aged 50±21.9 years, uninsured (37.0%), with falls (37.9%) and motor vehicle collisions (35.8%) as the leading causes of injury. All race and insurance interaction groups except Hispanic with insurance had significantly more subsequent emergency healthcare visits compared to the Non-Hispanic White with private insurance reference group (p\u3c0.05) with Non-Hispanic Black with Public insurance having the greatest relative risk (RR: 4.04; CI: 3.43, 4.77). Conclusion: There is considerable variation with the amount of healthcare utilization services when considering race and insurance status. Interventions to target at risk groups are imperative to reduce these disparities

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI)

Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to the attention control (0%). To broaden the accessibility of the intervention we will complete an RCT to assess the efficacy of telehealth delivery (tGLB-TBI) by enrolling 88 participants over a 3 year period. Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health. The long-term goal is to reduce health inequities and broaden program dissemination to people with TBI that lack access due to environmental barriers, including living rurally or lacking transportation

Utilization and access to healthcare services among community-dwelling people living with spinal cord injury

<p><b>Objective</b>: Describe the utilization, accessibility, and satisfaction of primary and preventative health-care services of community-dwelling individuals with spinal cord injury (SCI).</p> <p><b>Design</b>: Cross sectional, in-person or telephonic survey, utilizing a convenience sample.</p> <p><b>Setting</b>: Community.</p> <p><b>Participants</b>: Individuals with SCI greater than 12-months post injury.</p> <p><b>Interventions</b>: N/A.</p> <p><b>Outcome measures</b>: Demographic, injury related, and 34-item questionnaire of healthcare utilization, accessibility, and satisfaction with services.</p> <p><b>Results</b>: The final sample consisted of 142 participants (50 female, 92 male). Ninety-nine percent of respondents had a healthcare visit in the past 12-months with primary care physicians (79%), with SCI physiatrists (77%) and urologists (50%) being the most utilized. 43% of the sample reported an ER visit within the past 12-months, with 21% reporting multiple visits. People who visited the ER had completed significantly less secondary education (P = 0.0386) and had a lower estimate of socioeconomic status (P = 0.017). The majority of individuals (66%) were satisfied with their primary care physician and 100% were satisfied with their SCI physiatrist. Individuals who did not visit an SCI physiatrist were significantly more likely to live in a rural area (P = 0.0075), not have private insurance (P = 0.0001), and experience a greater decrease in income post injury (P = 0.010).</p> <p><b>Conclusion</b>: The delivery of care for people with SCI with low socioeconomic status may be remodeled to include patient-centered medical homes where care is directed by an SCI physiatrist. Further increased telehealth efforts would allow for SCI physiatrists to monitor health conditions remotely and focus on preventative treatment.</p

Utilization of overground exoskeleton gait training during inpatient rehabilitation: a descriptive analysis

Abstract Background Overground exoskeleton gait training (OEGT) after neurological injury is safe, feasible, and may yield positive outcomes. However, no recommendations exist for initiation, progression, or termination of OEGT. This retrospective study highlights the clinical use and decision-making of OEGT within the physical therapy plan of care for patients after neurological injury during inpatient rehabilitation. Methods The records of patients admitted to inpatient rehabilitation after stroke, spinal cord injury, or traumatic brain injury who participated in at least one OEGT session were retrospectively reviewed. Session details were analyzed to illustrate progress and included: “up” time, “walk” time, step count, device assistance required for limb swing, and therapist-determined settings. Surveys were completed by therapists responsible for OEGT sessions to illuminate clinical decision-making. Results On average, patients demonstrated progressive tolerance for OEGT over successive sessions as shown by increasing time upright and walking, step count, and decreased assistance required by the exoskeleton. Therapists place preference on using OEGT with patients with more functional dependency and assess feedback from the patient and device to determine when to change settings. OEGT is terminated when other gait methods yield higher step repetitions or intensities, or to prepare for discharge. Conclusion Our descriptive retrospective data suggests that patients after neurological injury may benefit from OEGT during inpatient rehabilitation. As no guidelines exist, therapists’ clinical decisions are currently based on a combination of knowledge of motor recovery and experience. Future efforts should aim to develop evidence-based recommendations to facilitate functional recovery after neurological injury by leveraging OEGT