Clinical Research Directory

Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)

Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.

Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group

Background Reperfusion therapies, i.e., intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT), are most effective treatments in the management of acute ischemic stroke (AIS) patients. The benefits of reperfusion therapies, however, may be reduced by treatment delays due to tests and examinations and logistic issues. Emergency Stroke Unit (ESU), a new concept of stroke unit locating at the Accident and Emergency Department (AED), equipped with a mobile, low-field MR imaging (lfMRI) scanner for fast diagnosis of ischemic stroke, differentiation of intracranial hemorrhage and identification of large vessel occlusion (LVO), is being tested in Mainland China. It may shorten the door-to-needle time (DNT) for IVT and door-to-groin puncture time (DPT) for EVT, which may hance associate with improved functional outcomes of AIS patients. This is a prospective, single-center, open-label, non-randomized, single-arm study aims to evaluate the safety and efficacy of the ESU workflow using lfMRI in shortening the DNT/DPT and improving functional outcomes in AIS patients, who are eligible for IVT and/or EVT and can be treated within 6 hours after onset, compared with standard practice in Hong Kong; to reveal the changes in the ischemic lesions over a few days after IVT/EVT in these patients, with serial follow-up lfMRI exams.

Stroke Care During the COVID-19 Pandemic

Background: The SARS-CoV-2 pandemic led to substantial changes in the allocation of healthcare resources and affected the behavior of patients experiencing stroke symptoms. Previous studies have mainly focused on the so-called "first wave" of the pandemic during the first half of 2020. During this period, the number of hospital admissions of patients with transient ischemic attacks (TIAs) and minor strokes decreased significantly in many hospitals. This reduction was attributed not only to the reallocation of healthcare resources toward the care of patients with COVID-19, but also to patients' concerns about becoming infected with SARS-CoV-2 during a hospital stay. Since then, the situation has changed, as hospitals have become better prepared to treat patients with COVID-19 and the public has become better informed about the risks of SARS-CoV-2 infection. It is therefore possible that the pattern of acute stroke care during the subsequent wave of COVID-19, which began in autumn 2020, differed from that observed during the first wave. Aim: The aim of this project is to analyze changes in patterns of acute stroke care across different regions of Europe during the first and subsequent waves of the COVID-19 pandemic and to identify epidemiological determinants associated with changes in stroke care. Methods: We will collect and analyze data on hospital admissions of patients with acute ischemic stroke, hemorrhagic stroke, and transient ischemic attacks (TIAs) from approximately 40 participating stroke units across Europe for the period from January 1, 2019, to June 30, 2021. The following parameters will be collected: Number of hospital admissions per month and mean length of hospital stay (LOS) per month from January 1, 2019, to June 30, 2021, for the following diagnoses: ischemic stroke hemorrhagic stroke transient ischemic attack Monthly numbers of thrombolysis and thrombectomy procedures during the same period. Epidemiological parameters: population density, population age, geography of the region, urban/rural region properties, traffic connection to the first European hot spot of Covid-19, number of nursing homes Care characteritics: hospital size, stroke unit capacity. Statistical analysis: Changes in the number of stroke admissions and length of hospital stay, as well as rates of thrombolysis and thrombectomy, will be analyzed in relation to regional COVID-19 incidence and mortality rates and other epidemiological parameters, including epidemiological connectivity to the first European COVID-19 hotspot. Expected outcomes: We aim to identify regional patterns of change in acute stroke care during different phases of the COVID-19 pandemic and to determine epidemiological factors associated with these changes.

Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

The goal of this clinical trial is to learn how a partially self-supervised constraint-induced movement therapy (sCIMT) program in adults with arm and hand weakness will work after stroke. This study will look at whether the program can help people improve the use of their arm and hand after a stroke while requiring less time with a therapist. The main questions it aims to answer are: * Does the sCIMT program help people use their affected arm and hand better - after a stroke? * Do participants feel that the sCIMT program is useful, easy to follow, and a good fit for their recovery needs? * Does taking part in the sCIMT program improve participants' quality of life and daily well-being? Participants will: * Take part in a therapy program 5x/week for 2 weeks. The program is designed to help improve the use of the arm and hand affected by stroke. * Wear a mitt on the stronger hand during certain practice activities to encourage use of the weaker hand. * Complete surveys and tests before and after the program to measure arm and hand use, experiences with the program, and quality of life.

Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data

The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants. Indications Studied: Apparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs). Study Design: Single-country, multicenter, prospective, longitudinal survey. Objectives: The study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting. The study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.

Pemafibrate for Symptomatic ICAS RCT

The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA). The main questions this study aims to answer are: 1. Does pemafibrate lower the chance that ICAS gets worse over 12 months? 2. Does pemafibrate improve TG levels and other vascular risk markers? 3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months? Researchers will compare a pemafibrate group with a non-pemafibrate group to see whether pemafibrate helps prevent progression of ICAS. This is an open-label, randomized, parallel-group trial. That means participants are assigned by chance to 1 of 2 groups, and both the researchers and participants know which group was assigned. Participants in both groups will continue to receive standard stroke care, including antithrombotic therapy and management of vascular risk factors such as blood pressure, low-density lipoprotein cholesterol, diabetes, and smoking. Participants may be eligible if they are 18 years or older, have clinically stable ischemic stroke or TIA, have 50% to 99% stenosis in a symptomatic intracranial artery on contrast-enhanced CT angiography (CTA), and have elevated fasting (\>=150 mg/dL) or non-fasting (\>=175 mg/dL) TG levels. Some people will not be eligible, such as those with ICAS due to non-atherosclerotic arterial disease, severe extracranial carotid stenosis, recent intravenous thrombolysis or mechanical thrombectomy, planned revascularization, contraindications to pemafibrate or iodinated contrast media, dialysis, or pregnancy. Participants will: * Be randomly assigned to a pemafibrate group or a non-pemafibrate group * Take pemafibrate for 12 months if assigned to the pemafibrate group, with possible dose adjustment based on TG levels and kidney function * Have blood tests and clinical assessments at baseline and during follow-up * Undergo brain CTA at study entry and again at 12 months * Undergo brain MRI/MRA and vascular tests such as ankle brachial index, cardio ankle vascular index, and pulse wave velocity according to the study schedule * Be followed for vascular events, functional outcome, and adverse events for 1 year

Cawthorne-Cooksey Exercises and Frenkel Exercises on Balance and Coordination in Stroke

Stroke, often caused by cerebral circulation disruption can lead to transient or permanent brain function deficit it is a leading cause of disability and death globally, with a particularly high burden in low- and middle-income countries like Pakistan. Balance and coordination impairments are common post-stroke, severely impacting patients' mobility and quality of life. While Cawthorne-Cooksey and Frenkel exercises are low-cost rehabilitation techniques known to aid balance and coordination, there is limited evidence comparing their effectiveness in stroke patients. This study aims to evaluate and compare the effects of Cawthorne-Cooksey and Frenkel exercises on improving balance and coordination in post-stroke patients. Specific goals include determining which protocol leads to faster and more sustained improvements and providing evidence-based recommendations for stroke rehabilitation.

Accelerated rTMS for Post-Stroke Apathy

This pilot study will investigate the safety, feasibility, tolerability, and preliminary efficacy of accelerated high-dose repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC) to address apathy symptoms in individuals with chronic stroke.

Trunk Impairment Scale - Adaptation and Validation in French

The objective of this project is to verify the validity and determine the clinimetric properties after translation and adaptation into French of the Trunk Impairment Scale (TIS), a scale for measuring trunk control and seated balance.

Risk Factors, Costs, and Impacts of ED Boarding

The goal of this observational study is to learn about the risk factors, costs, and operational impacts of emergency department boarding (patients admitted to the hospital but remaining in the emergency department awaiting placement on an inpatient floor) The main questions it aims to answer is: 1. What characteristics of patients make them more likely to experience ED boarding? 2. What is the impact of ED boarding on costs of health care? 3. How do high-boarding environments affect the clinical care of all patients in the emergency department, including those that do not board themselves. Data will be secondary in nature, collected in the regular Participants already taking intervention A as part of their regular medical care for RA will answer online survey questions about their joint pain for 5 years.

Functional Electrical Stimulation Versus Whole-Body Vibration in Post-Stroke Rehabilitation

This study will compare the effects of Functional Electrical Stimulation (FES) and Whole Body Vibration Training (WBVT) on lower limb motor control, balance, and physical performance in post-stroke patients. It will be a single-blinded randomized clinical trial including 34 participants, who will be allocated into two groups. Both groups will receive their respective interventions 4 days per week for 8 weeks. Outcomes will be assessed at baseline and after 8 weeks using the Fugl-Meyer Assessment for lower extremity motor control, Berg Balance Scale for balance, and Barthel Index for physical performance.

Pnf Techniques vs Mirror Therapy

to check the effectiveness of mirror therapy and pnf techniques on lower limb mobility in stroke patients

Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Narrowing of the carotid artery due to atherosclerosis with an unstable plaque can cause a stroke. Patients with carotid artery disease who have had a TIA or minor stroke and are at high risk of another stroke are often treated with surgery or stenting to remove the plaque. For lower-risk patients, medication alone is the better option, as surgery also carries risks. A new decision method, based on MRI detection of unstable plaques (IMPROVE), can better assess stroke risk and help determine which patients do or do not need surgery. We are investigating whether this method is at least as effective as the standard approach, which mainly considers the degree of narrowing. We expect that this new method will help reduce strokes and lower healthcare costs. Patients will be followed for several years to compare which method is better for health and costs.

Comparative Effects of Somatosensory Stimulation and Task Based Mirror Therapy in Post Stroke Patients

This randomized controlled trial will be conducted at the Department of Physical Therapy, DHQ Hospital Sheikhupura, over duration of eleven months. A total of 20 stroke patients meeting inclusion criteria will be conveniently sampled and randomly assigned into two groups. Group A will receive somatosensory stimulation, while Group B will undergo task-based mirror therapy. Interventions will be administered five times per week for four weeks. Upper limb function will be assessed at baseline and post-intervention using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Action Research Arm Test (ARAT), and the Box and Block Test (BBT) to assess upper limb motor function, task based performance and gross motor dexterity. Data analysis will be performed using SPSS version 26.

NORA-HOME: An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient Ischemic Attacks

In this project, we aim to validate a Home Hospitalization plan for patients with TIA or minor stroke. Our hypothesis is that our Multimodal Home Hospitalization program (NORAHOME) for patients with TIA and minor stroke is safe, reduces the complications associated with conventional hospitalization, and is more efficient than Standard Clinical Practice. To conduct the study, we require the voluntary participation of patients with TIA and minor strokes.

Early Functional Proprioceptive Stimulation Post-stroke

The main objective of our study is to evaluate the impact of the use of Functional Proprioceptive Stimulation (FPS) on the recovery of the postural and motor functional capacities of the patient in the subacute phase of a stroke. The hypothesis is that the use of FPS has a positive impact on the recovery of the patient's functional abilities, as well as on the duration of treatment until the sit/stand transfers are completed. To evaluate this potential effect,there will be a randomization with two groups : one will have 5 sessions a week for 6 weeks maximum of SPF and the other groupe will have the same sessions but with the device stettled but not activated.

Mirror Therapy on Motor Recovery and Pain of Hemiparetic Arm

evaluate the effect of mirror therapy on motor recovery and pain of hemiparetic arm post stroke

Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System

To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)

[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease

This clinical trial aims to evaluate whether \[¹⁸F\]AlF-OC PET/MRI can characterize and quantify inflammation in carotid atherosclerotic plaques. The study will assess if tracer uptake in culprit and non-culprit carotid arteries, measured by standardized uptake values (SUV), is associated with future cerebrovascular events. Specifically, it will examine whether \[¹⁸F\]AlF-OC uptake predicts the risk of recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular complications. Participants will undergo \[¹⁸F\]AlF-OC PET/MRI and will be followed via telephone interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA.

Characterising the Neuromuscular Function of Post Stroke Patients

Strokes are a leading cause of death and disability in developed countries, with significant economic and social impacts. Defined by the WHO, strokes cause rapid and lasting disturbances in cerebral function. In the UK, strokes occur every five minutes, affecting 100,000 people annually and resulting in substantial physical impairments and financial costs. Although stroke-related deaths have decreased due to improved treatments and awareness, strokes remain a major cause of death and disability worldwide, especially in lower-income countries. Strokes typically cause unilateral deficits, leading to significant daily challenges and necessitating tailored rehabilitation strategies such as CIMT, FES, and VR Rehab. As the population ages, innovative neurorehabilitation approaches are essential to enhance functional recovery post-stroke. This pilot study aims to better understand the neuromuscular deficits caused by stroke to inform and improve future rehabilitation interventions, including the potential use of force accuracy training (FAT)

The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3)

Stroke is a major cause of death and disability worldwide, frequently resulting in persistent cognitive deficits among survivors. These deficits negatively impact recovery and therapy engagement, and their treatment is consistently rated as high priority by stakeholders and clinicians. Although clinical guidelines endorse cognitive screening for post-stroke management, there is currently no gold standard approach for identifying cognitive deficits after stroke, and clinical stroke services lack the capacity for long-term cognitive monitoring and care. Currently available assessment tools are either not stroke-specific, not in-depth or lack scalability, leading to heterogeneity in patient assessments. To address these challenges, a cost-effective, scalable, and comprehensive screening tool is needed to provide a stroke-specific assessment of cognition. The current study presents such a novel digital tool, the Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3), designed to detect both domain-general and domain-specific cognitive deficits in patients after stroke with minimal input from a health professional. To ensure its reliability, we will utilise multiple validation approaches, and aim to recruit a large normative sample of age-, gender-, and education-matched UK-based controls. Moreover, the IC3 assessment will be integrated within a larger prospective observational longitudinal clinical trial, where post-stroke cognition will be examined in tandem with brain imaging and blood biomarkers to identify novel multimodal biomarkers of recovery after stroke. By leveraging this rich dataset, our study will allow more precise targeting of cognitive rehabilitation to stroke survivors that are most at risk of progressive cognitive decline and have the greatest potential for recovery.