Stroke Clinical Trials

The purpose of this research study is to find out the optimal intensity and frequency of Low Intensity Focused Ultrasound (LIFU) that is safe and tolerable in people who have had a stroke. 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

The objective of this project is to investigate the validity of a handheld spasticity measurement tool against standard clinical measurements of spasticity. We propose the testing apparatus will accurately provide an equivalent clinical measure of spasticity while also providing a more precise estimation of spastic response in persons with stroke. Read Less

For the breathing intervention, participants completed two experimental sessions at least two weeks apart. The experimental sessions were randomized between the slow-breathing condition (6 breaths/min) or the control breathing condition (12 breaths/min). Breathing interventions were 15 minutes in length and completed with the assistance of the breathing app, Breathe Deep (Mineev, Bizi Apps LLC). The breathing intervention is currently completed. The reliability and validity study of AFAS is ongoing. This is a one-time visit for participants in which participants will undergo screening of sensation and movement as well as fill in some questionnaires. Read Less

Acute stroke systems of care should emulate trauma systems which deliver the full range of care to all injured patients by means of organized, coordinated efforts in defined geographic areas. Just as trauma systems have proven ability to save lives of the most severely injured patients, clinicians should have a stroke system able to provide care to patients with the most severe strokes. The most severe type of acute ischemic stroke is due to proximal large vessel occlusion (LVO). Mechanical thrombectomy (MT) offers an extraordinary potential to improve the outcome of patients with LVO. Unfortunately, in part because MT is available only at advanced stroke centers, only a minority of patients with LVO are treated with MT, and there are racial, socioeconomic, and rural disparities in access to MT. Based on the success of trauma systems and our prior collaboration, the Alabama Department of Public Health (ADPH) is planning a five-year statewide quality improvement initiative of trauma communications center (TCC) coordinated severity-based stroke triage (SBST) which aims to transform the fragmented acute stroke care system by coordinating prehospital and inter-facility emergency stroke care. Read Less

Stroke survivors experience motor deficits, weak voluntary muscle activations, and low weight-bearing capacity that impair ambulation. Restoring motor function is a priority for people post-stroke, whose gait patterns are slow, and metabolically inefficient. The role of the ankle is crucial for locomotion because it stores mechanical energy throughout the stance phase, leading to a large activation of plantarflexor muscles during push-off for propulsion. After a stroke, paretic plantarflexors undergo changes in their mechanics and activation patterns that yield diminished ankle power, propulsion, and gait speed. Recovery of lost plantarflexor function can increase propulsion and mitigate unnatural gait compensations that occur during hemiparetic walking. In the stance phase, dorsiflexion is imposed at the ankle and the plantarflexors are loaded, which results in excitation of group Ia and II afferents, and group Ib afferents. Load sensing Ib afferents are active in mid-late stance, and through spinal excitatory pathways, reinforces the activation of plantarflexors and propulsive force generation at the ankle. Targeting the excitability of the load sensitive Ib excitatory pathway, propulsive soleus activity and resulting force generation (and thereby gait speed) can be improved after stroke. The long-term research goal is to develop a novel hybrid gait paradigm integrating operant conditioning and powered wearable devices to advance neuro-behavioral training and enhance locomotor ability after stroke. The overall objectives are to 1) modulate the soleus muscle loading response within the stance phase, and 2) develop a dynamic protocol to operantly condition the soleus response in stroke survivors. The central hypothesis is that enhancing the soleus loading response in mid-late stance phase through operant up-conditioning can increase plantarflexor power and forward propulsion after stroke. In working towards attaining the research objective and testing the central hypothesis, the objective of this pilot study is to modulate the soleus loading response in the stance phase during treadmill walking. The specific aims in this study are to 1) apply ankle perturbations in mid-late stance phase combining a control algorithm and a powered device to characterize the changes in soleus EMG between perturbed and unperturbed (i.e., when no perturbations are applied) step cycles in 15 able-bodied individuals; and 2) determine the feasibility of the wearable ankle device and its algorithm in 5 participants with hemiparesis and gait deficits due to a stroke. The testing of the device and its algorithm will provide foundational evidence to adjust the soleus stimuli continuously and reliably, and develop the new walking operant conditioning protocol for stroke survivors. An expected outcome in this pilot is to lay the groundwork to develop the soleus up-conditioning protocol as a potential strategy to improve paretic leg function. If successfully developed, this new protocol proposed in a subsequent study will be the first neurobehavioral training method that targets spinal load-sensitive pathways to improve ankle plantarflexor power and forward propulsion after stroke. Read Less

Every year approximately 15,000 Veterans are hospitalized for stroke, and up to 40% of those Veterans will experience stroke-related language impairment (i.e., aphasia). Stroke-induced aphasia results in increased healthcare costs and decreased quality of life. As the population of Veterans continues to age, there will be an increasing number for Veterans living with the aphasia and its consequences. Those Veterans deserve to receive aphasia treatment designed to facilitate the best possible outcomes. In the proposed study, the investigators will investigate optimal treatment intensity and predictors of treatment response for a novel word retrieval treatment. The knowledge the investigators gain will have direct implications for the selecting the right treatment approach for the right Veteran. Read Less

Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention. Read Less

The Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic and subacute period following stroke (Goffredo et al., 2019; Molteni et al., 2017; Molteni et al., 2021; Nam et al., 2019; Rojek, 2019). Exoskeleton-assisted gait training during acute inpatient rehabilitation provides a means for patients to actively participate in gait training during the early and most severe stages of stroke recovery. Most acute inpatient rehabilitation facilities (IRFs) report a feasibility of 5-8 Ekso sessions during inpatient stays and demonstrate significant improvement from baseline (Nolan et al., 2020; Swank, 2020). Nolan et al. (2020) demonstrated that stroke patients receiving Ekso ambulated 1640 feet more than patients undergoing more conventional gait training techniques during inpatient rehabilitation, suggesting that the exoskeleton may offer additional benefit during this phase of recovery. Despite promising evidence, there have been no randomized controlled trials within the IRF setting. Because Ekso-gait training increases the number of steps patients can take, during acute inpatient physical therapy (PT), the investigators hypothesize that patients who participate in Ekso-gait training will demonstrate quicker improvements in balance, gait speed, endurance and independence in functional ambulation during their stay in the IRF. In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or Ekso-gait training therapy. Meaningful clinical benchmarks for balance and walking will be assessed using the Berg Balance Scale (BBS) (Alghadir, 2018; Moore, 2018), the 10 Meter Walk Test (10MWT) (Bowden, 2008; Moore, 2018), the Six Minute Walk Test (6MWT) (Kubo et al., 2020; Moore, 2018), and Functional Ambulation Category (FAC) (Mehrholz, 2007). Achieving these benchmark scores are associated with several positive outcomes, including increased ability to ambulate in the community and reduced risk of falling (Alghadir, 2018; Bowden, 2008; Kubo et al., 2020). The investigators also hypothesize that patients in the Ekso cohort will report greater value/usefulness when compared to patients receiving standard care. Read Less

Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life. This study is one of two that are part of a larger grant. This record is for sub-study 2, which will evaluate the benefits of adaptive trial spacing. Read Less

This study will enroll stroke patients and healthy participants. Participants will complete baseline measures followed by a music playing task during fMRI and simultaneous measurement of motor response using electromyography (EMG) and accelerometry and affective response using electrodermal activity (EDA) and self-reports. The music task consists of tapping an MRI-compatible MIDI drum with either: (1) improvisation or maintaining the beat and (2) live or recorded piano accompaniment. The primary objectives are to identify the motor, affective, and neural outcomes of improvisation and live accompaniment in music playing tasks. Read Less