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Stroke clinical trials

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NCT ID: NCT04758052 Withdrawn - Clinical trials for Spinal Cord Injuries

Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement

BEGASTON
Start date: March 31, 2021
Phase: N/A
Study type: Interventional

There is currently no prospective study analyzing the effect of tracheostomy with bedside simultaneous gastrostomy versus tracheostomy with delayed gastrostomy placement (TSG versus TDG) on the outcomes of neurocritically-ill patients. The investigators will study TSG via concomitant PDT and PUG procedures, while TDG will occur per usual care. This study is a prospective randomized open-label blinded endpoint study to assess the effect of tracheostomy with bedside simultaneous gastrostomy (TSG) versus the usual care of tracheostomy with delayed gastrostomy (TDG) placement on outcomes of neurocritically-ill patients.

NCT ID: NCT04637100 Withdrawn - Stroke Clinical Trials

Gaming Apps Post-Stroke

GAPS
Start date: December 2021
Phase: N/A
Study type: Interventional

The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.

NCT ID: NCT04607876 Withdrawn - Stroke Clinical Trials

Family at Risk Study

FAR
Start date: October 2021
Phase: N/A
Study type: Interventional

Atherosclerotic cardiovascular disease (ASCVD) risk factors include hypertension as a key risk factor, as well as hyperlipidemia, diabetes, smoking, obesity, diet, inactivity, family history and age. These are highly prevalent in the US population with risk factor control far from optimal.1-3 Hypertension affects approximately 30% of adults and the US Preventive Services Task Force (USPSTF) supports population screening.4 Many individuals have multiple risk factors, with declining rates of control with an increasing numbers of risk factors,5 but greater benefit through the control of multiple risk factors.6 Prior approaches to primary and primordial ASCVD risk mitigation generally fail to target motivated populations for identification and modification of risk factors. Data from the ongoing project C3FIT has shown first-degree relatives of a stroke patient are such a highly motivated population, having seen the end result of failed ASCVD risk control in their relative. Also, family history of stroke or heart disease is an independent risk factor for ASCVD including stroke and heart attack7-11 and there is a family risk-factor clustering putting this group at higher risk.12-14 However, current clinical practice does not seize the opportunity to assess and intervene on the family members of individuals with stroke or CAD despite their being enriched with individuals at elevated risk and high motivation to reduce that risk. The Family at Risk (FAR) Trial targets this high-risk/high-motivation population of the biological offspring and siblings of an index stroke patient. FAR will evaluate two strategies for risk factor control: 1) FAR-Education/Coaching Arm (FAR-EC Arm): providing education from the American Heart/American Stroke Association (AHA/ASA) and coaching on risk factor control, versus 2) FAR-Enhanced Intervention Arm (FAR-EI Arm): the education and coaching strategy described above plus a combined virtual and in-person m-health management strategy to modify ASCVD risk factors using HealthStream/Harmonize technology. This supplemental management includes a home-based and family-focused participant-centric strategy for identification of ASCVD risk factors, education tailored to participant needs, and implementation of a technology-enabled m-health management strategy. This management strategy, known as "Harmonize" was shown to efficiently manage risk factors in Project Trident (Remote Patient Monitoring Pilot for High Risk Patients, IRB#: 2018-0063-HCP; Nov 2018 - Nov 2020) that aimed to improve control of cardiovascular risk factors in an eldery (mean age = 79 years), racially mixed, primary prevention population (Pulicharam, publication in process). Adoption of research into a clinical environment depends not only on the efficacy of the therapy, but the quality of the evidence supporting its utilization, and the acceptance of the therapy to patients and caregivers. Major national groups have low level evidence supporting real world approaches to management of these risk factors (USPSTF recommendations "Insufficient" or "B" or "C"). While specifically not developing a guideline, FAR seeks to fill that gap with high quality research data that will inform guidelines and health system approaches to primary prevention, and assess the acceptability of approaches to the affected participant population; leading to dissemination of study results to a real-world setting. By incorporating input from patients, physicians (internal medicine, primary care, and neurology), nurses, and the AHA in the design, implementation, and dissemination of study results, study investigators anticipate good acceptance of study results. FAR will inform key stakeholders (stroke patients, their first-degree relatives, and the healthcare system) regarding the prevalence and impact of family history as an ASCVD risk factor, and how best to mitigate that risk. This effort will be conducted in two phases. During the feasibility phase, the relatives of stroke patients will be assessed regarding their current level of recognition of risk, their willingness to engage in risk measurement, the feasibility of remote monitoring, educational and behavioral factors that would lead to behavior change. Simultaneously, primary care physicians (PCPs) will be assessed regarding perceptions of care gaps, feasibility of use of the chronic disease management technology,20 and design features that might present issues; with development and testing of educational and motivational materials and content. The full-study phase will consist of monitoring the longitudinal thread of integration of the feasibility findings into the main project; initiating the final protocol and assess outcomes; and, activating the Engagement Committee for input into identified study issues.

NCT ID: NCT04580238 Withdrawn - Hemorrhagic Stroke Clinical Trials

Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache

Start date: December 2023
Phase: Phase 1
Study type: Interventional

Post stroke headache occurs in approximately 10-23% of all stroke patients. Its onset is shortly after experiencing a stroke, or stroke like event, and persists for at least three months. These headaches have features which resemble migraine or occur in people who have a previous history of migraine that was once infrequent. Botox is a treatment that is currently approved for the treatment of chronic migraine, that is migraine headaches occurring for at least 15 days a month for at least 3 months. Given the clinical similarity in character and frequency of post stroke headache and migraine, and the fact that stroke affects structures like the blood vessels in the brain that are also affected in migraine, this study is to investigate the possible role that Botox would have in the treatment of Post-Stroke Headache.

NCT ID: NCT04575909 Withdrawn - Clinical trials for Right Hemispheric Stroke

Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This study is an investigation of a behavioral speech and language treatment for emotional prosody recognition and production deficits in subacute right hemisphere stroke.

NCT ID: NCT04482842 Withdrawn - Stroke Clinical Trials

Gene-guided Warfarin for Anticoagulation Therapy

GWAT
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.

NCT ID: NCT04377425 Withdrawn - Stroke, Acute Clinical Trials

COVID-19 Prevalence and Cognitive Deficits in Neurological Patients

Neuro-Covid
Start date: May 7, 2020
Phase:
Study type: Observational

The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms

NCT ID: NCT04361552 Withdrawn - Clinical trials for Coronary Artery Disease

Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Start date: April 7, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

NCT ID: NCT04344626 Withdrawn - Stroke Clinical Trials

Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery

Start date: July 16, 2018
Phase: N/A
Study type: Interventional

Refractory epilepsy, meaning epilepsy that no longer responds to medication, is a common neurosurgical indication in children. In such cases, surgery is the treatment of choice. Complete resection of affected brain tissue is associated with highest probability of seizure freedom. However, epileptogenic brain tissue is visually identical to normal brain tissue, complicating complete resection. Modern investigative methods are of limited use. An important subjective assessment during surgery is that affected brain tissue feels stiffer, however there is presently no way to determine this without committing to resecting the affected area. It is hypothesized that intra-operative use of a tonometer (Diaton) will identify abnormal brain tissue stiffness in affected brain relative to normal brain. This will help identify stiffer brain regions without having to resect them. The objective is to determine if intra-operative use of a tonometer to measure brain tissue stiffness will offer additional precision in identifying epileptogenic lesions. In participants with refractory epilepsy, various locations on the cerebral cortex will be identified using standard pre-operative investigations like magnetic resonance imagin (MRI) and positron emission tomography (PET). These are areas of presumed normal and abnormal brain where the tonometer will be used during surgery to measure brain tissue stiffness. Brain tissue stiffness measurements will then be compared with results of routine pre-operative and intra-operative tests. Such comparisons will help determine if and to what extent intra-operative brain tissue stiffness measurements correlate with other tests and help identify epileptogenic brain tissue. 24 participants have already undergone intra-operative brain tonometry. Results in these participants are encouraging: abnormally high brain tissue stiffness measurements have consistently been identified and significantly associated with abnormal brain tissue. If the tonometer adequately identifies epileptogenic brain tissue through brain tissue stiffness measurements, it is possible that resection of identified tissue could lead to better post-operative outcomes, lowering seizure recurrences and neurological deficits.

NCT ID: NCT04265079 Withdrawn - Stroke Clinical Trials

I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke

Start date: February 2021
Phase: N/A
Study type: Interventional

The upper extremity kinematics of people post-stroke will be monitored with/without an inactive hand orthosis (intervention: added weight to hand) during ARAT, Fugl-Meyer, and Box and Blocks tests. Measurements will occur right after inclusion and repeated once after 7-8 weeks. Upper extremity kinematics and test scores will indicate the influence of additional weight to hand as a possible confounder when, in the future, the hand orthosis would be used as a therapy tool.