Stroke Clinical Trials

The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide. Read Less

The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics. Read Less

The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. Read Less

Objective: The goal of this study is to implement and test a neuro-mechanical gait assist (NMGA) device to correct walking characterized by muscle weakness, incoordination or excessive tone in Veterans with hemiparesis after stroke that adversely affects their ability to walk, exercise, perform activities of daily living, and participate fully in personal, professional and social roles. Research Plan: A prototype NMGA device will be used to develop a finite state controller (FSC) to coordinate each user's volitional effort with surface muscle stimulation and motorized knee assistance as needed. Brace mounted sensors will be used to develop a gait event detector (GED) which will serve the FSC to advance through the phases of gait or stair climbing. In addition, a rule-base intent detection algorithm will be developed using brace mounted sensors and user interface input to select among various functions including walking, stairs climbing, sit-to-stand and stand-to-sit maneuvers. The FSC controller tuning and intent algorithm development and evaluation will be on pilot subjects with difficulty walking after stroke. Outcome measures during development will provide specifications for a new prototype NMGA design which will be evaluated on pilot subjects to test the hypothesis that the NMGA improves walking speed, distance and energy consumption of walking. These baseline data and device will be used to design a follow-up clinical trial to measure orthotic impact of NMGA on mobility in activities of daily living at home and community. Methodology: After meeting inclusion criteria, pilot subjects will undergo baseline gait evaluation with EMG activities of knee flexors and extensors, ankle plantar and dorsiflexors and isokinetic knee strength and passive resistance. They will be fitted with a NMGA combining a knee-ankle-foot-orthosis with a motorized knee joint and surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. Brace mounted sensor data will be used for gait event detector (GED) algorithm development and evaluation. The GED will serve the FSC to proceed through phases of gait based on supervisory rule-based user intent recognition algorithm detected by brace mounted sensors and user input interface. The FSC will coordinate feed-forward control of tuned stimulation patterns and closed-loop controlled knee power assist as needed to control foot clearance during swing and stability of the knee during stance. Based on data attained during controller development and evaluation, a new prototype NMGA will be design, constructed and evaluated on pilot subjects to test the hypothesis that a NMGA device improves safety and stability, increases walking speed and distance and minimizes user effort. Clinical Significance: The anticipated outcome is improved gait stability with improved swing knee flexion, thus, increasing the safety and preventing injurious falls of ambulatory individuals with hemiplegia due to stroke found in large and ever-increasing numbers in the aging Veteran population. Correcting gait should lead to improved quality of life and participation. Read Less

This study is a necessary and important step in the development of a new therapy for upper limb functional recovery in patients with severe motor impairment. It is the first clinical trial of non-invasive brain stimulation (repetitive transcranial magnetic stimulation or rTMS) delivered to excite the undamaged hemisphere (specifically the contralesional higher motor cortices or cHMC) in stroke. Therefore, this study will determine whether the positive results obtained in our short-term pilot study can be made to last longer and produce functional benefits in severe patients with the application of brain stimulation in combination with long-term rehabilitation therapy. Rehabilitation therapy administered is called contralaterally controlled functional electrical stimulation (CCFES). Determining whether combining rTMS facilitating the cHMC with CCFES produces synergistic gains in functional abilities in severe patients is necessary for acceptance by the clinical community and to move this technology toward commercialization and widespread dissemination. The proposed study will determine whether the combination of rTMS facilitating the cHMC with CCFES produces greater improvements in upper extremity function in severe participants who are ≥6 months from stroke onset than the combination of rTMS facilitating the damaged hemisphere (specifically the ipsilesional primary motor cortex, iM1) and CCFES or the combination of sham rTMS and CCFES. The secondary purposes are to define which patients benefit most from the treatments, which may inform future device and treatment development and clinical translation, and to explore what distinct effects the three treatments have on the brain. To accomplish these purposes, we are conducting a clinical trial that enrolls severe stroke patients. Read Less

Caring for a family member after a stroke can be very difficult and worsen the physical and mental health of untrained caregivers. The TASK III intervention is a unique, comprehensive caregiver intervention program that enables caregivers to develop the necessary skills to manage care for the survivor, while also taking care of their own health. Read Less

After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke. Read Less

This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation. Read Less

The goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. The main questions it aims to answer are: Can participants self-regulate reflex excitability Can participants self-regulate reflex, reduce spasticity and improve walking Participants will undergo surface stimulation to evoke spinal reflexes and will be asked to control these reflexes therefore reducing spasticity. Researchers will compare result to able bodied participants to see if [insert effects] Read Less

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis. Read Less

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke. Read Less

The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below: Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out, as defined by TOAST classification of subtypes of acute ischemic stroke. Aim 2: In cases of ischemic strokes of unknown or "cryptogenic" etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic. Read Less