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NCT05600374
We will investigate the therapeutic efficacy of EEG-synchronized noninvasive repetitive transcranial magnetic stimulation (rTMS) in the early subacute phase after ischemic stroke to improve upper limb motor rehabilitation. We hypothesize that synchronization of rTMS with the phase of the ongoing sensorimotor oscillation indicating high corticospinal excitability leads to significantly stronger improvement of paretic upper limb motor function than the same rTMS protocol non-synchronized to the ongoing sensorimotor oscillation or sham stimulation.
NCT05471375
The purpose of this study is to develop a database that contains movement and rehabilitation-related data collected through the use of wearable sensors and video. This database will serve as a resource for clinicians and researchers interested in the investigation of movement or rehabilitation-related research ideas.
NCT07578844
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.
NCT04875936
The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.
NCT07084025
This pilot experimental study aims to describe the feasibility of a cognitive strategy training protocol : PRPP-I, in activities of daily life across home-based setting for adults with chronic stroke for improvement of independence and quality of life. Aditionnally to examine preliminary effectiveness of PRPP-I protocol within a home-based setting on functional cognitive strategies, independence, quality of life and career burden.
NCT07575867
This is a prospective, non-randomized, observational cohort study conducted at the FSBI "NMRC TPM" of the Ministry of Healthcare of the Russian Federation. Left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation for preventing cardioembolic events in patients with atrial fibrillation. However, the optimal post-procedural antithrombotic regimen following LAAC remains unclear, with no consensus on evidence-based therapy. Given current trends in cardiology favoring reduced-intensity antithrombotic strategies, this study aims to contribute to the evidence base by evaluating whether LAAC followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy is superior to long-term standard-dose DOAC therapy in patients with non-valvular atrial fibrillation.
NCT06292117
The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel. The main questions this study aims to answer are: * What are the best strategies to implement this genetic test in the hospital? * Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke? Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test.
NCT04402125
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years.
NCT06749197
Rationale: Patients with acquired brain injury (ABI) may suffer from persistent cognitive deficits and/or subjective cognitive complaints, especially in the domains of attention and working memory. Cognitive deficits are associated with anxiety and depression and may affect social participation and health-related quality of life (HR-QoL). Approximately 25% of the patients with ABI will be referred to an in- and/or outpatient rehabilitation center for multidisciplinary therapy to optimize recovery. Multiple studies suggest that supervised computerized cognitive training (CCT) may enhance cognitive functioning in patients with ABI. Recently, the CCT program RehaCom was introduced as an online version which is suitable for home training. In this study the feasibility and outcomes of implementing home-based CCT into a blended care pathway will be investigated in patients receiving outpatient rehabilitation therapy after ABI. Objective: The aim of this study is to assess the feasibility and to evaluate the effect of blending a home-based CCT program (RehaCom) in standard care on cognitive functioning in patients after ABI. The secondary aim is to evaluate the effect of this CCT program on subjective cognitive complaints, self-efficacy, psychological outcome measures and HR-QoL. Study design: Randomized cross-over trial comparing a 5-week blended care pathway to 5 weeks of standard care within 30 patients with ABI. Study population: Adults with ABI receiving outpatient rehabilitation therapy. Intervention: A blended care pathway including 1 cognitive strategy training session of 1 hour per week in the outpatient rehabilitation center in combination with home-based CCT in 4 sessions of 30 minutes per week, during 5 weeks. The standard care pathway includes 2 cognitive training sessions of 1 hour per week in the outpatient rehabilitation center during 5 weeks. Main study parameters/endpoints: Cognitive functioning (attention and working memory), self-efficacy, psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed at baseline (T0), after 6 weeks (T1) and after 12 weeks (T2). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the blended care pathway patients will be instructed to follow a home-based CCT program. Training at home requires a time investment from patients but will also reduce the number of visits to the rehabilitation center. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment instead of traveling to the rehabilitation center for scheduled cognitive training. Increasing patients' responsibility in their recovery process may improve their self-efficacy and HRQoL. Completion of online questionnaires also requires a certain time investment from patients and might lead to temporary fatigue. Patients may take a break at any moment and continue completing the questionnaires at a later time. By a maximum duration of 45 to 60 minutes per measurement we aim to minimize the burden for patients. There are no risks associated with participation.
NCT05686642
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
NCT06767631
Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.
NCT05785598
Transcranial Doppler ultrasonography with injection of contrast agent (intravenously to enhance the ultrasound signal) is a non-invasive technique that has been used for years to study intracranial vessels that constitute the polygon of Willis. However, this technique does not allow good visualization of small vessels, such as perforating arteries. Ultrasound localization microscopy (ULM) is based on the principle of localizing injected microbubbles in order to follow their movement to map the microvascular structure. The concentration of these microbubbles must remain low (in contrast to its classical use in Doppler ultrasound) in order to isolate and localize them. By using the same images as those performed in clinical routine by Doppler ultrasound and by processing the data offline, ULM would increase the resolution by a factor of 10 allowing potential observation of perforating arteries.
NCT03366129
Background: A stroke occurs when not enough blood reaches the brain. Sometimes stroke causes changes in certain brain matter. This is called white matter hyperintensity (WMH) and can lead to mental decline. But not all WMH is caused by stroke. Not all people with WMH experience mental decline. Researchers want to learn more about WMH. They want to see if it is related to disruptions in the blood-brain barrier. Objective: To better understand the how blood-brain barrier disruption is related to white matter hyperintensities. Eligibility: Adults at least 18 years old who have been admitted to a study site with stroke-like symptoms Design: Participants will be screened with an MRI scan and cognitive tests. Participants will have 11 visits over 6 years. Each visit will be 3-4 hours. At each visit, participants will: Update their medical history Have a thin plastic tube (catheter) inserted into an arm vein by needle Have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will be in the scanner about 60 minutes, lying still for up to 20 minutes at a time. They will get earmuffs for loud sounds. Have a dye injected through the catheter during the MRI Have tests of movement, language, and cognition Some participants will have an extra visit for an MRI in a stronger scanner (7T MRI). Participation for some participants will be authorized by their legal representative. ...
NCT04534556
Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.
NCT06358313
Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever small vessel stroke patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects.
NCT03992404
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
NCT05128513
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). A recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, the investigator argues that DELP may exert neuroprotective effect on acute cerebral hemorrhage (ACH). In this context, the prospective, random, open-label, blind-endpoint, multi-centre study is designed.
NCT07546448
This study aims to evaluate the relationship between serum electrolyte levels and the development of contrast-induced acute kidney injury (CI-AKI) in patients with acute ischemic stroke undergoing endovascular therapy (EVT). Contrast-induced nephropathy remains a significant complication associated with endovascular procedures and is linked to increased morbidity and mortality. While several risk factors have been identified, the role of serum electrolyte imbalances in the development of CI-AKI has not been fully elucidated. In this retrospective cohort study, patients treated with EVT between 2018 and 2026 will be analyzed. Patients will be classified based on the presence or absence of CI-AKI according to changes in serum creatinine levels. Demographic data, comorbidities, laboratory parameters-including serum electrolytes-and procedural variables will be compared between groups. The primary objective is to determine whether serum electrolyte levels are associated with the risk of CI-AKI. Secondary objectives include evaluating 90-day mortality and dialysis dependency in patients who develop CI-AKI.
NCT07527013
The RESCUE-BP is a multi-centered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. In patients with acute ischemic stroke who have undergone endovascular treatment and achieved successful recanalization, the evaluation will compare a stratified blood pressure management strategy based on the collateral circulation status with the guideline-recommended conventional blood pressure management strategy. Within each stratum, participants will be randomized in a 1:1 ratio to either the stratified blood pressure management strategy group or the guideline-recommended conventional blood pressure management group. The goal is to determine whether this can improve good functional outcomes at 90 days (90-day Modified Rankin Scale \[mRS\] score 0-2). The study consists of four visits including the day of randomization, 24±4 hours after randomization, 7±1 days after randomization and 90±7 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment, neurological function rating scale will be recorded during the program. The primary outcome is the modified Rankin Scale (mRS) score of 0 to 2 at 90±7 days after randomization. The primary safety outcome is the incidence of sICH within 24±4 hours after randomization.
NCT02369770
Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.