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Stroke, Acute clinical trials

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NCT ID: NCT04047563 Completed - Stroke, Acute Clinical Trials

Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke

Start date: November 10, 2019
Phase: Phase 3
Study type: Interventional

In the present prospective, multicentric, randomized, double-blind, parallel, saline-controlled phase II clinical study; the investigators plan to evaluate the efficacy of sovateltide (IRL-1620 or PMZ-1620) therapy along with standard supportive care in patients of acute ischemic stroke.

NCT ID: NCT04044807 Completed - Stroke, Acute Clinical Trials

Feasibility of the mNIHSS in Surgical Patients

Start date: August 6, 2019
Phase:
Study type: Observational

This prospective observational study will be assessing whether it is practical and feasible to use a stroke screening tool (the modified NHISS, mNIHSS) in an adult surgical population. Perioperative stroke is an uncommon but devastating complication of surgery and previous research suggests that stroke symptoms may be missed in this population. This stroke screening tool has been used extensively in non-surgical patients but has not be used in non-cardiac surgical patients. Surgical patients have additional factors that may affect their ability to complete this assessment such as pain medications and sedatives, pain, and use of epidurals and nerve blocks. This study will involve a total of five testing sessions. The first will occur at the time of consent to screen for cognitive impairment via the Montreal Cognitive Assessment (MoCA), as part of our exclusion criteria. Then over the course of four subsequent visits, participants will be assessed on the mNIHSS to track for any changes before and after their procedure, as well as evaluate the real-life usability of the mNIHSS as a potential tool to screen for stroke in the surgical population.

NCT ID: NCT04042584 Completed - Stroke Clinical Trials

Visio-conference for Pre-hospital Triage of Stroke Suspicions

OPTIC-AVC
Start date: November 20, 2019
Phase: N/A
Study type: Interventional

Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

NCT ID: NCT04001738 Terminated - Stroke, Acute Clinical Trials

Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial (ANGIOCAT)

ANGIOCAT
Start date: August 14, 2018
Phase: N/A
Study type: Interventional

To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.

NCT ID: NCT04000971 Active, not recruiting - Stroke Clinical Trials

Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care

C3FIT
Start date: February 25, 2020
Phase: N/A
Study type: Interventional

Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health. Scientific evidence that identifies the best stroke care delivery design is lacking. We completed a three-year, Centers for Medicare & Medicaid Services (CMS) Health Care Innovation Award that tested a new stroke care design called an Integrated Practice Unit (IPU). This IPU was developed through stakeholder input from patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies. This IPU design was associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost. Based on the CMS study, a larger, pragmatic trial was developed that is called C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT will randomly assign approximately 22 US hospital sites to continue Joint Commission-certified Comprehensive/Primary (CSC/PSC) design or to the novel Integrated Stroke Practice Unit (ISPU) design for stroke care. C3FIT's ISPU uses team-based, enhanced collaboration (called Stroke Central) and follows patients from presentation at the Emergency Department (ED) through 12-months post-discharge (called Stroke Mobile). Stroke Mobile includes a nurse and lay health educator team who visit patients and caregivers at home or at a rehabilitation or skilled nursing facility to assess function and quality of life using telehealth technology to facilitate access to multiple providers. Results from C3FIT will provide high quality scientific evidence to determine the best stroke care design that ensures positive health for patients and caregivers.

NCT ID: NCT03994822 Completed - Clinical trials for Cardiovascular Diseases

pRESET for Occlusive Stroke Treatment

PROST
Start date: October 4, 2019
Phase: N/A
Study type: Interventional

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

NCT ID: NCT03968068 Completed - Stroke, Acute Clinical Trials

Exercise and RIC and TCD

Start date: June 7, 2019
Phase: N/A
Study type: Interventional

The first week after a stroke is a particularly important time, as improving blood flow may limit secondary ischaemic damage to the brain and help reduce the overall burden neurological injury and future disability. Small studies in patients with stroke have shown that moderate aerobic exercise increases blood flow to the brain, however, no studies have evaluated the safety of aerobic exercise within the first week after stroke, nor whether it results in changes to cerebral blood flow. Remote ischaemic conditioning (RIC) is when ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. These changes often result in improved blood supply to various areas of the body. The use of RIC in the acute period after stroke is currently being investigated in a number of large randomised controlled trials e.g. RECAST, RESIST, however, our understanding of how RIC actually works is incomplete. Importantly, there is scarce data on the acute effects of RIC on cerebral blood flow (CBF), a potentially pivotal mechanism behind its effects. We propose an exploratory study to evaluate whether it is feasible, acceptable and safe to undertake low and moderate intensity aerobic exercise or remote ischaemic conditioning (RIC) in patients during the acute period after stroke, and whether either of these interventions result in changes to cerebral blood flow velocity (CBFv) in the major cerebral arteries. We will compare any changes to those in a cohort of healthy volunteers.

NCT ID: NCT03964662 Enrolling by invitation - Stroke Clinical Trials

Stroke Home Rehabilitation With WeReha

WR
Start date: December 18, 2018
Phase: N/A
Study type: Interventional

WeReha is an innovative device for the home rehabilitation of stroke patients developed within the scope of the EU funded project MAGIC-PCP [5]. WeReha is a system that allows patients to perform exercises in a home environment with remote supervision integrated within regular rehabilitation. The principle on which the product is based is that of biofeedback guided rehabilitation, designed to stimulate muscle recovery and contribute to a more effective and more motivating rehabilitation of neuro-motor patterns. WeReha is completely adaptable, allowing only authorized to assign exercises, by planning specific sequences of movements. WeReha product is composed by the following elements: - a tablet with a proprietary application on it (the "WeReha app") - an inertial sensor with accelerometers, gyroscopes and magnetometers (the "sensor") - elastic straps allowing the user to wear it on different parts of the body (the "straps") - a series of 3D printed objects where the sensor can be placed that become animated (the "smart objects") - a web portal for clinical staff through which they can manage and monitor users (the "web-application") The WeReha app presents the patient with a series of rehabilitation exercises in the form of a number of interactive games, driven by body movement, which is captured by the sensor or the hand specific movements using the smart objects. A session with WeReha always starts with a questionnaire on the system, through which the software gains an understanding of the patient's health conditions and the presence or not of a caregiver for the session. Based on this questionnaire, the software adapts the daily session to minimise risks while maintaining a high level of rehabilitation to help the patient reach their goals. The device works with and without an internet connection, but when the device is connected to the internet, supervisors are able to provide supervision and remote support through a web application. The web application is hosted on a dedicated server located inside the hospital. Only trained staff will be provided with access to the web application with a unique username and password required for sign on. The exercises assigned for the client to perform at home, are at the discretion of the clinician who is caring for the patient and might require the presence of a caregiver. The goal of this study is to investigate the applicability and utility of an innovative technology product such as WeReha to the home rehabilitation of stroke patients as an integrative solution to a conventional exercise program and to assess its acceptance by the patient, caregivers and clinic professionals. Patients will use WeReha for their home rehabilitation in addition to traditional treatments for up to 12 weeks. The Inclusion criteria for the study have been kept broad in order to assess these factors on a large enough scale, so as not to limit the usage of the device to a specific sub-group of patients. If patients enrolled are in a subacute phase (i.e. within the first 6 months after the stroke onset), they will be enrolled before leaving the hospital or the rehabilitation department and reaching their home. If patients are considered to be in their chronic phase (i.e. over 6 months after stroke onset), they will be enrolled during an outpatient treatment or on a volunteer basis. Before starting the trial with WeReha, every patient enrolled will receive proper training from a person dedicated to the project (who will be referred to as the "dedicated figure") appointed by the hospital and financially supported by the sponsor of the study.

NCT ID: NCT03957278 Terminated - Stroke, Acute Clinical Trials

A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

Start date: August 15, 2019
Phase: N/A
Study type: Interventional

This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.

NCT ID: NCT03948906 Active, not recruiting - Stroke, Acute Clinical Trials

Stroke and Rehabilitation in North of Norway and Central Denmark

Start date: April 2014
Phase:
Study type: Observational

Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.