Stroke Clinical Trials

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions. Read Less

The purpose of this proposal is to use novel video-based movement tracking technology to measure gait quality after stroke - in the home. Current rehabilitation practice assesses walking in the highly controlled 'ideal' clinical environment. The implicit assumption by clinicians and researchers is that the way people walk in the clinic (their best capacity) reflects the way they walk in the real-world (true performance). With advances in computer vision and development of pose estimation algorithms, it is now possible to directly measure how people are walking in their homes. It is critical that researchers apply this technology to examine the basic assumptions that underlie current rehabilitation practice. Here, a video-based pose estimation workflow will be used to 1) contrast the gait patterns of persons post-stroke as observed in-clinical vs. in-home settings, and 2) map the rate of deterioration of clinically-derived walking improvements, in the home. This methodology has been used to accurately measure gait kinematics in people with stroke as they walk in laboratory, however this study now seeks to use these methods to record people with stroke as they walk in their natural home environments. The ultimate outcome of this project will not only be freely-available video-based workflow modified for home-based gait assessments, but also preliminary data revealing how people with stroke walk in the real world. Read Less

Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations. Read Less

The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure, health outcomes, patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients. The main question\[s\] it aims to answer are: 1. Does providing a free home blood pressure cuff improve control of hypertension? 2. Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations? 3. Does improved control of home blood pressure decrease adverse patient outcomes? Participants will be asked to * Take their blood pressure at home and records the results * Participate in follow-up phone calls from investigators at at 3 and 6 months Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education Read Less

The goal of this observational study is to learn about cognitive outcomes in stroke patients. The main question it aims to answer are: 1. Is blood-brain barrier permeability compromised for years after stroke, 2. Is a blood biomarker of imbalanced angiogenesis dysregulated in chronic stroke and 3. Are there biomarkers that separately or together predicts cognitive decline after stroke, and are other MRI, blood, and clinical characteristics that are associated. Participants will undergo cognitive testing and MRIs two years apart. Researchers will compare cognitive outcomes in non-stroke patients who have cardiovascular risk factors to understand the effects of stroke on these outcomes. Read Less

The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are: Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function? Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation. Read Less

The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped. Read Less

This pilot project aims develop a need-based community stroke self-management program that would improve the stroke self-management self-efficacy and competencies among African American stroke survivors living in rural Alabama. This study is a mixed-methods study to collect data related to the needs of these individuals and develop a need-based intervention based on the actual needs/ preferences of our target population. The specific aims are to assess the needs, access barriers, existing resources for a stroke self-management program; and develop a Community Stroke Self-management Program for improving stroke survivors' abilities to manage their medication adherence, diet, Physical Activity (PA) requirements, symptoms, and psychological distress to better meet their needs, expectations, and preferences. Another aim is to examine the feasibility and acceptability of delivering the CSSP after tailoring the proposed intervention in Aim 2a) among the AA chronic stroke survivors living in rural Alabama. Read Less

Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke. Read Less

Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. \[Epub ahead of print\] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. \[EPub Ahead of Print\]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population. Read Less

Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Yet, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that 1) identifying the most significant disruptions and 2) developing a cognitive-behavioral intervention to promote psychosocial functioning post-stroke is particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery. Read Less

In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) related to improvements in both motor and cognitive recovery following the use of taVNS in acute stroke patients. Read Less