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Stroke clinical trials

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NCT ID: NCT06308952 Not yet recruiting - Clinical trials for Degree of In-stent Stenosis (as Measured by WASID Method) at the 12th ±1 Month Annual Angiographic Follow-up

Effectiveness of Atorvastatin in Preventing Cerebrovascular Events After Flow Diverter Implantation

Start date: July 5, 2024
Phase: Phase 4
Study type: Interventional

In recent years, with the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). It is a revolutionary treatment method, which has changed the concept of endovascular treatment of IA, and turned the previous endovascular embolization to the reconstruction of the parent artery. At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. The postoperative mortality was 1.5%, of which 1.3% were caused by delayed aneurysm rupture, distal parenchymal hemorrhage and PED-related nerve compression symptoms. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antibody therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients. Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. Although the mechanism of clinical benefit of lipid-lowering by atorvastatin is not completely clear, a large number of clinical evidence has shown that atorvastatin can also reverse atherosclerosis, stabilize plate, reduce inflammation, reverse vascular endothelial dysfunction and reduce microthrombosis. It can reduce the incidence of cardiovascular and cerebrovascular events in patients with coronary heart disease and internal carotid artery stenosis after stent implantation in different degrees. However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. In a retrospective observational study involving 273 patients empirically treated with atorvastatin for unruptured IA in our center, the median follow-up period was 7.6 months. The incidence of cerebrovascular events was 3.27%, and the incidence of more than 50% in-stent stenosis was 8.4%, which was significantly lower than the incidence of related events reported at home and abroad. Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation.

NCT ID: NCT06307834 Not yet recruiting - Stroke Clinical Trials

Restoring Grasp Ability in Stroke Survivors Through MI-Based Training

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function. This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors.

NCT ID: NCT06307743 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke

RAPID-SAVE
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation.

NCT ID: NCT06306144 Not yet recruiting - Minor Stroke Clinical Trials

Early-phase Telecare Programs for Minor Stroke

COGaDOM
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Minor strokes (few acute neurological symptoms ; NIHSS score <5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation. However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment. Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.

NCT ID: NCT06303869 Not yet recruiting - Stroke Clinical Trials

Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke

Start date: November 2024
Phase: N/A
Study type: Interventional

The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.

NCT ID: NCT06301815 Not yet recruiting - Stroke Clinical Trials

Feasibility of Measuring Vertical Perception in Acute Stroke

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

The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is: • To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss. Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments. If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting.

NCT ID: NCT06301646 Not yet recruiting - Clinical trials for Cerebrovascular Accident

Oral Enteral Nutrition Tube Feeding on Stroke Survivors

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are: Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

NCT ID: NCT06301607 Not yet recruiting - Stroke Clinical Trials

The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

NCT ID: NCT06301412 Not yet recruiting - Ischemic Stroke Clinical Trials

Combination of Hypothermia and Thrombectomy in Acute Stroke

COTTIS-2
Start date: March 18, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion. The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed. Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications.

NCT ID: NCT06299059 Not yet recruiting - Stroke Clinical Trials

Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients

Start date: March 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.