Ischemia

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 PETMR 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 PETMR 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 PETMR 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.

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 the safety and early effectiveness of an injectable drug called IMC-001 in improving the stability of atherosclerotic plaques in patients diagnosed with acute coronary syndrome ACS, which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, randomized, double-blind, placebo-controlled study is being conducted at two centers and aims to better understand how IMC-001 affects plaque stability in these patients. The study involves two dose groups with nine subjects each, where six receive IMC-001 plus optimal medical therapy and three receive a placebo plus optimal medical therapy. Participants will receive injections of either IMC-001 or placebo alongside standard treatments for coronary artery disease. The trial includes a dose escalation design to assess safety and preliminary efficacy. Participants will be monitored for changes in coronary artery low-attenuation plaque volume using coronary computed tomography angiography CCTA at baseline and again six months after treatment. The study will track safety, plaque volume changes, and other clinical assessments during the treatment and follow-up periods. The total participation duration includes the treatment phase and a six-month evaluation after dosing to assess the primary outcome measure.

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 brains 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 methodsmuscle stimulation of the arm using functional electrical stimulation FES and neurostimulation through the tonguecan 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 evaluating the maximum safe and tolerated dose of Levetiracetam LEV for treating neonatal seizures. This Phase IIb, open-label dose-escalation study aims to determine if higher doses of LEV than currently used can improve seizure control in newborns. The study includes infants at risk or confirmed to have neonatal seizures of mild to moderate severity, with continuous video EEG monitoring used to assess seizure activity and control. Participants initially receive a 60 mgkg dose of LEV. If seizures persist after this dose, they are randomized to either receive higher doses of LEV 90 mgkg, 120 mgkg, or 180 mgkg in increments or treatment with Phenobarbital PHB at 20-40 mgkg. Maintenance treatment with PHB may continue for five days either intravenously or orally if tolerated. The study includes three phases, with Phase 3 expanding to neonates with more severe seizure burden if earlier phases show efficacy. Throughout the study, participants are monitored with continuous EEG reviewed by neurophysiologists to assess seizure control over 24 hours and changes in seizure burden during the two hours after treatment. Safety, pharmacokinetics, seizure freedom rates, adverse events, and long-term outcomes up to eight years are evaluated. The study also assesses new technology for neonatal seizure detection. Participation may last several years due to extended follow-up for long-term outcomes.

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 mcgkg 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 mcgkgmin and the other at 2.0 mcgkgmin. 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 evaluating the effectiveness of a smart upper limb rehabilitation system combined with exoskeleton robot devices and an Internet of Things IoT application for home-based training in patients recovering from stroke and those with spinal cord injuries. The study aims to improve motor function, daily living activities, and quality of life by remotely monitoring rehabilitation progress and assisting patient movements. Participants are adults aged 20 to 79 years with specific cognitive and physical criteria depending on their condition. Participants are randomly assigned to one of two groups the TIGER group, which uses a tenodesis-induced-grip exoskeleton robot system, or the TOT group, which receives task-oriented training. Each group follows a home-based training program for 4 weeks. For stroke patients, training is 30 minutes twice daily, 5 days a week for spinal cord injury patients, training is 40 minutes once daily, 5 days a week. The TIGER system offers passive range of motion warm-up and functional training, while the TOT group practices sensorimotor techniques and functional tasks. Participants will undergo assessments before and after the intervention, including motor function tests like the Fugl-Meyer Assessment and Box and Block Test, range of motion measurements, and quality of life evaluations. Researchers will monitor progress in motor activity, independence, and satisfaction with assistive technology. The total study duration spans from baseline through 4 weeks of training, with outcome measures collected at baseline and after the intervention period.