Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.
This study is enrolling adults between the ages of 18-60 who have a Patent Foramen Ovale (PFO). A PFO is a slit-like opening between the upper chambers (called atria) of the heart. This opening allows blood to flow between these chambers which can lead to a stroke. This study is examining an investigational device called the Encore PFO closure device. An investigational device is one that is not yet approved for commercial use by the US Food and Drug Administration (FDA) but is approved for use in this study. This study will last approximately 5 years and involve 9 visits. This is a randomized study meaning participants will be randomly assigned to receive the investigational PFO closure device or an FDA approved PFO closure device. Participants have a 50:50 chance to receive either device. Study related testing includes physical exams, blood test, echocardiogram (ultrasound test of the heart) electrocardiograms or ECG (test of the electrical activity of the heart) and the procedure to place the PFO closure device. There are risks involved with this study including access site related risks, bleeding and bruising, incomplete closure of the PFO with the closure device or other device related complications. There is potential benefit including reduced risk of a recurrent stroke.
This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.
The purpose of this research study is to study the utility of advanced blood testing for patients who have had a stroke and tend to form blood clots more than usual. The study involves blood tests using a new testing system that may detect issues with blood clotting easier than conventional tests. This is a 12-month study and will involve one blood draw and follow-up phone calls
The purpose of this study is to investigate the efficacy of the oral FXIa inhibitor asundexian in prevention of ischemic stroke and its safety (bleeding) compared with placebo on top of background antiplatelet therapy in adult participants after an acute non-cardioembolic ischemic stroke or high-risk TIA.
This study aims to improve the breastfeeding skills of premature or sick term infants with non-invasive, transcutaneous vagus nerve stimulation (taVNS). taVNS is microcurrent stimulation to the ear, which targets a vagus nerve branch. Pairing taVNS with motor activity, such as breast feeding, may help with motor learning in infants as it does in adults with stroke. Ten premature infants older than or equal to 35 weeks gestational age, or convalescing sick term infants whose mothers want to breastfeed will participate in this study with parental consent. Infants will receive 1 taVNS treatment paired with breastfeeding per day for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort. This level of electrical stimulation will be delivered by a TENS unit (Transcutaneous elecrical nerve stimulation) and neonatal electrodes applied just in front of the ear and our custom made carbon electrode used in the BabyStrong studies (#10881, #67997). Stimulation will be timed with latching and sucking for the duration of the feed and will be on with sucking and off with rest. Pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow efficiency will be recorded. Parental satisfaction will be assessed by questionnaires at the beginning, after 1 and 2 weeks, and 3 months after the end of treatment to assess infants' progress in and maintenance of breastfeeding abilities.
If pairing breastfeeding with taVNS is able to improve effective breastfeeding in infants in the neonatal intensive care units, it might help premature and sick term infants to successfully breastfeed at the time of discharge and maintain breast feeding at home after discharge. Premature infants may benefit from longer time receiving maternal breastmilk.
VA Principal Investigators plan to gather information about veterans at the VAHCS who are interested in participating in rehabilitation research. Subject information collected will be housed in a centralized Rehabilitation Research Repository. VAHCS investigators may access this repository to quickly identify and recruit individuals who wish to be contacted for current and future VA IRB R&D approved rehabilitation research.