Acute Stroke

Carotid artery plaque rupture is a leading cause of ischemic stroke, and early, accurate assessment of plaque vulnerability can help prevent these strokes. Researchers are studying the use of 18F FDG and 68Ga-FAPI PET/MR imaging to investigate features of vulnerable carotid plaques, such as active fibrosis and inflammation, which may better identify unstable plaques compared to standard MRI alone. This observational study aims to clarify imaging characteristics linked to plaque instability in patients with carotid artery plaques. Participants will undergo 18F FDG and 68Ga-FAPI PET/MR scans to assess metabolic and structural plaque features. Treatments such as medication, carotid stenting, or carotid endarterectomy will follow clinical guidelines but are not assigned by the study. The study focuses on evaluating plaque vulnerability through advanced imaging rather than testing specific treatments. During the study, participants will be monitored for stroke and cerebral hemorrhage at 1, 6, and 12 months after their PET/MR scan. Researchers will also assess the openness of the carotid artery (lumen patency rate) and analyze imaging results at these same time points. This approach aims to track plaque changes and clinical outcomes over one year to better understand plaque behavior and risk.

Aneurysmal subarachnoid hemorrhage (SAH) is a severe type of stroke that can cause early brain injury, vasospasm, and delayed cerebral ischemia. These complications are usually diagnosed using brain imaging techniques like CT scans, MRI, and arteriography, which require moving critically ill patients within the hospital, posing risks. This research aims to evaluate a new non-invasive bedside device using 3D enhanced ultrasonography to detect the main arteries in the brain's anterior circulation, potentially improving diagnosis without the need for transportation. Participants with aneurysmal SAH affecting the anterior circulation will undergo three bilateral transcranial enhanced ultrasonography scans using a device with microbubble contrast agent (Sonovue), performed at three key risk periods: days 0-2, 4-10, and 11-14. This pilot study will not alter standard care but will assess the quality of the imaging signal and compare findings with clinical outcomes. The study plans to include 15 patients at a single center. During the study, patients will receive the enhanced ultrasonography scans at bedside without moving to other hospital locations. Researchers will measure the presence and quality of the time-intensity curve from the contrast agent as the primary outcome. Secondary outcomes include comparing ultrasound data to clinical signs of brain injury and vasospasm, detecting principal arteries, and evaluating measurement consistency. The study will run until March 2025 and aims to assess feasibility and potential clinical benefits.

Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training (CAR-ST) to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups: CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points: before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions' impact.

Researchers are evaluating whether neflamapimod, a drug that inhibits the enzyme p38 alpha kinase, can improve physical disability and cognitive problems after moderate to severe acute ischaemic stroke. This is a phase 2, randomized, double-blind, placebo-controlled study focused on recovery following stroke in adults aged 45 and older. The study is sponsored by EIP Pharma Inc and aims to assess motor recovery and functional improvements over 12 weeks of treatment. Participants will be assigned to one of several groups receiving either neflamapimod or a placebo. The drug and placebo are given as capsules taken with food either three times daily or twice daily for 12 weeks. The study includes two cohorts with differing capsule dosing schedules. The treatment phase lasts for 12 weeks, during which the effects of neflamapimod on motor function and stroke recovery are evaluated. During the study, participants will undergo assessments including the Fugl-Meyer Assessment of Motor Recovery after Stroke, the Timed Up and Go Test, and the National Institutes of Health Stroke Scale to measure changes in motor skills and overall stroke severity. Additional measures include the Modified Rankin Scale and Barthel score to evaluate functional independence. The trial involves regular monitoring and evaluations from enrollment through the end of the 12-week treatment period.

Researchers are evaluating MT200605, a drug that acts like brain-derived neurotrophic factor (BDNF) by protecting brain nerve tissues and supporting energy production in the brain's striatum. This study focuses on patients who have had an acute ischemic stroke within 24 hours, aiming to see if MT200605 can help reduce brain injury and improve recovery. The trial is a Phase II exploratory study conducted at 32 centers in China, enrolling 360 patients. Participants will be randomly assigned to receive either a low, medium, or high dose of MT200605 or a placebo. All patients will also receive standard medical care. The study drug or placebo is given twice daily by intravenous infusion for 14 consecutive days. The trial uses a double-blind design, meaning neither participants nor researchers know which treatment is given. During the study, researchers will assess patients using the modified Rankin Scale (mRS) to measure disability three months after the stroke. They will also evaluate changes in the National Institutes of Health Stroke Scale (NIHSS) score two weeks after treatment. Safety, brain function, and recovery will be closely monitored throughout the trial, which starts in October 2025 and continues until June 2026.

Researchers are evaluating whether combining two non-invasive brain stimulation methods—muscle stimulation of the arm using functional electrical stimulation (FES) and neurostimulation through the tongue—can improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface (BCI) training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.

Researchers are conducting a large-scale, multicenter, prospective study to understand ischemic stroke better. The study focuses on collecting various biological samples like blood, feces, and urine from patients diagnosed with ischemic stroke to identify biomarkers linked to the condition. By combining demographic data, clinical indicators, imaging results, and biomarker information, the team aims to create models for risk assessment, early warning, and predicting patient outcomes. The study also seeks to identify key genes and explore related signaling pathways associated with ischemic stroke. Participants receive standard care, which may include intravenous thrombolysis with alteplase administered within the appropriate time window after stroke onset. The study groups include patients categorized based on prognosis as those with favorable or unfavorable outcomes. This observational study tracks patients over time without assigning specific treatments beyond usual care. Participants will undergo regular follow-up assessments, including monitoring cerebrovascular events and evaluating modified Rankin Scale scores three months after stroke onset. Various biological samples are collected to support biomarker analysis. The study involves ongoing data collection on clinical, imaging, and biological parameters to support the development of predictive models. The total duration and specific visit schedules vary by participant, with long-term follow-up planned under the study protocol.

This research aims to evaluate a digital treatment combining an iPad-based cognitive training program called AKL-T01 with metacognitive strategy coaching to improve executive dysfunction, depression symptoms, and daily function in individuals who have experienced a stroke. The study focuses on those with post-stroke depression and executive dysfunction, conditions linked to ongoing mood and cognitive challenges. Researchers will assess whether this combined treatment enhances brain connectivity and overall functioning compared to a control group. Participants in the intervention group will use the AKL-T01 program for 25 minutes a day, five days a week, over six weeks. This program involves multitasking exercises in a video game-like environment using an iPad. Alongside this, they will receive weekly 45-minute coaching sessions with a clinician to reflect on their experiences and develop strategies for daily activities. The control group will engage in general cognitive games on the iPad for the same duration and frequency, also paired with similar coaching sessions. Throughout the study, participants will undergo assessments at the start and end of the six-week treatment period. These include tests measuring executive function, depression symptoms, daily functioning, and brain connectivity through MRI scans. Researchers will monitor adherence to the treatment and evaluate changes using standardized tools such as the Oral Symbol Digit Modalities Test, Montgomery Asberg Depression Rating Scale, and resting state functional MRI. The total study duration for each participant is six weeks.

Researchers are investigating the effects of two different doses of bevifibatide citrate injection for patients who have had an acute ischemic stroke without large or medium-sized vessel blockage. This phase 2, single-center, randomized, double-blind trial aims to find a dose that improves neurological outcomes 90 days after stroke while minimizing the risk of symptomatic brain bleeding and serious side effects. The trial will provide important information to guide future larger studies on dosing. Participants receive bevifibatide citrate injection through an intravenous bolus of 220 mcg/kg over 1 to 2 minutes, followed by a continuous intravenous infusion for 24 hours. Two groups receive different maintenance infusion rates: one at 2.5 mcg/kg/min and the other at 2.0 mcg/kg/min. After the infusion and if imaging within 48 hours shows no significant brain bleeding, patients will take aspirin and clopidogrel tablets daily until day 90. Patients are also managed according to current stroke care guidelines, including possible use of low molecular weight heparin for blood clot prevention. During the study, participants will have neurological assessments using the modified Rankin Scale and National Institute of Health Stroke Scale at various time points up to 90 days. Brain scans will monitor for bleeding within 48 hours. Researchers will track adverse events, mortality, platelet aggregation inhibition, and quality of life. Follow-up lasts 90 days after treatment to evaluate both safety and neurological recovery. The total participation duration covers initial treatment and multiple assessments over this period.

Researchers are investigating treatments for people with small, unnoticed brain injuries called Covert Brain Infarcts (CBIs), which are often found by chance during MRI scans. CBIs do not cause symptoms initially but are linked to higher risks of stroke and death. The study aims to see if medications that prevent stroke, like blood thinners and cholesterol-lowering drugs, can help reduce these risks and whether CBIs increase the chance of dementia. Participants will be randomly assigned to one of four groups: one receiving a platelet inhibitor (either Aspirin or Clopidogrel) without statins, one receiving statin therapy (Atorvastatin or Rosuvastatin) without platelet inhibitors, one receiving both treatments, and one receiving neither treatment following current prevention guidelines. All groups will receive advice on lifestyle improvements and blood pressure management. Medication doses are carefully adjusted for tolerance, and the study follows a pragmatic, multicenter design. During the study, participants will be monitored for major cardiovascular and brain-related events, bleeding risks, dementia development, cognitive decline, and quality of life over 12 and 36 months. Assessments include MRI scans, physical activity levels, and various scales measuring daily living abilities, frailty, and neurological function. Researchers will also track serious adverse events and subtype characteristics of CBIs. The study duration spans at least three years with regular follow-ups to evaluate treatment effects and safety.