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Stroke clinical trials

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NCT ID: NCT06451887 Recruiting - Ischemic Stroke Clinical Trials

Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)

EMBRACE
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.

NCT ID: NCT06446960 Recruiting - Stroke Clinical Trials

The Role of Peripheral Afferents in Modulating Post-stroke Central Pain

APEDOC
Start date: February 12, 2024
Phase: Phase 3
Study type: Interventional

Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood. Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems. However, a recent study in a small cohort of patients has suggested that the peripheral nervous system (PNS) may have a role in the initiation and persistence of APD. The main objective of this prospective randomised controlled bicentric study (Raymond Poincaré and Ambroise Paré) in double blind and parallel groups against placebo (3 arms) will be to evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20 mg/ml or levobupivacaine 1.25 mg/ml or placebo (saline)

NCT ID: NCT06443840 Recruiting - Ischemic Stroke Clinical Trials

Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway

AUTONHOME
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The AutonHome® clinical investigation, proposed by Dr Charles FATTAL (coordinator of this study), and carried out by the Association Approche (delegated promoter), aims to use the AutonHome® selfeducation device for the rehabilitation of patients who have suffered a Cerebrovascular Accident (CVA), and thus respond to the problems of therapeutic discontinuity highlighted today. Neuradom's AutonHome® device combines self-education and telecare. This device makes it possible to carry out personalised self-education programmes supervised by the therapist, enabling the therapeutic link with the patient to be maintained without the need for the patient to travel. This tool has already proved its usability and perceived usefulness in a previous clinical study, which demonstrated the feasibility of a self-education programme for hemiplegic patients, based on feedback. AutonHome® was considered by users to be a relevant, useful and safe complement to conventional rehabilitation. On the basis of this feasibility study, the investigators wished to develop a second study around this AutonHome® device. In this second clinical investigation, in addition to perceived usefulness, the main objective is to demonstrate, in a population of stroke victims, that an experimental care pathway combining supervised self-education via AutonHome® with conventional re-education optimises the care pathway in terms of sensory-motor recovery, but also in terms of reduced length of stay and functional and medico-economic added value. This clinical trial involves two parallel arms. Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation, or into an experimental group, with self-rehabilitation and tele-rehabilitation in addition to conventional rehabilitation. The AutonHome study is a pilot study, with the aim of including 40 participants. Each centre will recruit 10 participants on a 1:1 randomisation basis, with 5 in the experimental group and 5 in the control group. Participants will be monitored for 15 weeks. This clinical investigation is multicentre, with 4 centres involved: the Centre Bouffard Vercelli (66962, Perpignan), the CMRRF de Kerpape (56275 Ploemeur), the association Saint-Hélier (35043, Rennes), and the Fondation ILDYS (29684 Roscoff).

NCT ID: NCT06443268 Recruiting - Quality of Life Clinical Trials

Cerebrovascular Disease: Quality of Life (CODE: QoL)

CODE:QoL
Start date: May 27, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers. The main question is: • to discover the factors associated with quality of life and stress in patient-caregiver dyads. Participants will be asked to fill out questionnaires and agree to provide a hair sample (in order to measure stress hormones in hair) and consent to use of their routine clinical and laboratory data. Researchers will compare a group of participants without stroke to establish a comparable baseline.

NCT ID: NCT06441552 Recruiting - Clinical trials for Cerebral Vascular Accident (CVA)/Stroke

The Natural History of Recovery After Stroke

RESTRO
Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this longitudinal observational study is to learn the course of recovery after stroke. Specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients.

NCT ID: NCT06430632 Recruiting - Stroke Clinical Trials

Early Robotic Gait Training After Stroke

ERA Stroke
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott & White Institute for Rehabilitation (BSWIR).

NCT ID: NCT06427746 Recruiting - Stroke Clinical Trials

Enhancing Prehospital Stroke Diagnosis

AIPO
Start date: November 1, 2022
Phase:
Study type: Observational

Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include: 1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel 2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.

NCT ID: NCT06426862 Recruiting - Stroke Clinical Trials

Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients

Start date: May 23, 2024
Phase: N/A
Study type: Interventional

This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).

NCT ID: NCT06424171 Recruiting - Stroke Clinical Trials

AFLETES-MRI: A Cardiac and Cerebral Magnetic Resonance Imaging Study in Athletes With Atrial Fibrillation

AFLETES-MRI
Start date: January 22, 2024
Phase:
Study type: Observational

Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF). In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice. In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke. To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously. The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.

NCT ID: NCT06421337 Recruiting - Acute Stroke Clinical Trials

BraiN20® Medical Device in Suspected Acute Stroke Patients

PROMISE-GLOB
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

Time is Brain company (http://www.tibtimeisbrain.com/about_us/) developed BraiN20®, a medical device to assess the presence and characteristics of the N20 signal of SEP. Investigators have demonstrated a high prognostic accuracy of N20 on functional recovery of patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) undergoing endovascular thrombectomy (EVT), the gold standard treatment. The aim if this new project is to validate BraiN20® in global patients presenting with suspected acute ischemic or hemorrhagic stroke in three comprehensive stroke centers in Spain. The primary objective is to establish the predictive performance of the presence of the N20 SEP over functional recovery as the primary outcome measure (likelihood of having a modified Rankin Scale (mRS) score 0-2 at 3 months evaluated by blinded independent raters). The effect will be measured by the metrics sensitivity, specificity, and predictive values, and compared with clinical and imaging predictive models by Receiving Operating Characteristics (ROC) curve analysis in the global population, stroke subtype and stroke mimics. Secondary aims are: 1) to determine the area under the curve (AUC) of the presence of the N20 SEP as biomarker of functional recovery in small subcortical infarctions and in patients with cortical infarctions and no large vessel occlusion; 2) to characterize N20 SEP signal in hemorrhagic stroke and stroke mimics; and 3) to evaluate the discriminant capacity of an explanatory new algorithm combining pre-hospital clinical variables and N20-SEP signal characteristics between ischemic, hemorrhagic and stroke mimics. This project would represent the first pilot study to validate the ability of BraiN20® to predict the functional recovery in the different types of acute stroke but also its ability to discriminate between stroke subtypes. Thus, BraiN20® monitoring could arise as a paradigm shift in acute stroke management, since it would standardize and accelerate patient triage, enable real time monitoring, increase access to EVT treatment and improve its outcome The trial is sponsored by Time is Brain S.L. and started in March 2024. Primary endpoint results are expected by the end of the 2024. BraiN20® could be a useful medical device aiding stroke subtype diagnosis and functional recovery.