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NCT ID: NCT05706168 Not yet recruiting - Stroke Clinical Trials

Effects of Aerobic Exercise on the Cerebral Arterial System, Cognitive, and Motor Function in Post-stroke Patients.

Start date: January 2023
Phase: N/A
Study type: Interventional

Background: Stroke is the second leading cause of death and disability worldwide and in Hong Kong, 6.2% of all registered deaths in 2020 were due to cerebrovascular disease. Exercise training has the potential to improve the deconditioned hemodynamic, motor, and cognitive functions associated with stroke. Purpose: The proposed study seeks to investigate the effects of AET on the large intracranial and extracranial cerebral arteries' morphological and haemodynamic features and the cognitive and motor functions in post-stroke chronic patients. Additionally, the study seeks to compare the cerebral arteries' features between post-stroke patients and age-matched controls without stroke. Furthermore, the project seeks to assess the association between the cerebrovascular system changes and the cognitive and motor function changes in post-stroke patients undergoing AET. Study Design: A Randomised controlled trial (RCT) in which the post-stroke patients will be randomly assigned into three groups consisting of a control group and two AET interventional groups (treadmill and cycle ergometer). Each group will target sample size of 20 participants. The target dosage for the two AET modes will consist of 1.) a session duration=30mins, 2.) frequency=3times/week, 3.) high intensity=(60-84% heart rate reserve (HHR).4.) Types=Treadmill and cycle ergometer 5.) overall program duration=3months. Data collection methods: Quantitative data on the cerebral arteries' haemodynamic and morphological features will be assessed using duplex carotid ultrasound (DCUS) and transcranial Doppler (TCD) ultrasound techniques. Montreal cognitive assessment (HK) version and six-minute walk test (6MWT) will assess cognitive and motor functions respectively. The data will be assessed at three time periods of during the 3 months AET program Significance of the study: The study has the potential to inform the clinical decision making process on the usefulness of AET in improving post-stroke chronic patients. Results on associations will provide a basis for future work in chronic stroke Rehabilitation functional outcome prediction models based on DCUS and TCD ultrasound imaging techniques.

NCT ID: NCT05703360 Not yet recruiting - Stroke Clinical Trials

Effectiveness of Audiovisual Stimulation in Immerisve Virtual Reality to Improve Visual Perception and Driving Performance

Re:DriVR
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effectiveness of an immersive virtual-reality (IVR) based stimulation program, in improving visual perception for people who have lost their driver's license due to perceptual or cognitive impairments. The main questions it aims to answer are: 1. Can the 6-week IVR stimulation program help improve driving performance? 2. Will participants experience improvement in visual detection and perception after training? Study Design Summary: - Participants will be randomized into a waitlist group or intervention-first group - The VR-based intervention will consist of training every 2 days for six weeks - Waitlist group will wait 6 weeks before starting intervention at study midpoint (week 7) - Intervention-first group will begin with intervention (week 1-6) and then stop intervention at study midpoint - Participants will complete tests related to driving performance, visual attention, and visual fields at the start of study, midpoint, and end of study Researchers will analyze data for changes from baseline in outcome measures.

NCT ID: NCT05702034 Not yet recruiting - Clinical trials for Ischemic Stroke; Ischemic Attack, Transient

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

LIBREXIASTROKE
Start date: February 9, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

NCT ID: NCT05701956 Not yet recruiting - Clinical trials for Basilar Artery Occlusion

Intravenous Tenecteplase and Mechanical Thrombectomy Techniques on 4.5 to 24 Hours After Basilar Artery Occlusion

Start date: February 2023
Phase: Phase 3
Study type: Interventional

Background and Rationale: Recently, two prospective multicenter RCT (ATTENTION and BAOCHE trials) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The EXTEND-IA TNK trial demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular thrombectomy for anterior circulation large vessel occlusion strokes. The COMPASS trial demonstrated the non-inferiority of functional outcomes when compared a direct aspiration as first pass thrombectomy with stent retriever first line thrombectomy in acute occlusion of anterior circulation. However, it is unclear whether intravenous tenecteplase bridging with endovascular thrombectomy is superior to endovascular thrombectomy alone in acute basilar artery occlusion and whether a direct aspiration as first pass thrombectomy is non-inferior to stent retriever first line thrombectomy in patients with basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of intravenous tenecteplase and a direct aspiration as first pass thrombectomy in these patients. Objective: 1. To assess the effect of intravenous tenecteplase plus endovascular thrombectomy compared to endovascular thrombectomy alone in patients with basilar artery occlusion (confirmed by CTA/MRA) on efficacy and safety outcomes. 2. to evaluate whether patients treated with a direct aspiration first pass (ADAPT) approach have non-inferior functional outcomes to those treated with a stent retriever as the firstline (SRFL) approach. Study design: Multicenter, prospective, controlled clinical trial with open-label treatment and blind outcome assessment (PROBE) of intravenous tenecteplase plus endovascular thrombectomy versus endovascular thrombectomy alone. The trial has observer blinded assessment of the primary outcome and of neuro-imaging at baseline and follow up.

NCT ID: NCT05701280 Not yet recruiting - Stroke Clinical Trials

Pilot/Pivotal Study of DBS+Rehab After Stroke

RESTORE
Start date: February 2023
Phase: N/A
Study type: Interventional

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

NCT ID: NCT05700591 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

rhPro-UK in Acute Ischaemic Stroke Within 4.5 Hours of Stroke Onset Trial 2(PROST-2)

PROST-2
Start date: February 2023
Phase: Phase 3
Study type: Interventional

Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose. RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK therapies have a potential advantage of less systemic bleeding in treated subjects. Data from several previous studies suggest that rhPro-UK is efficacious when used to treat patients with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the National Medical Products Administration to treat acute myocardial infarction. Since then, rhPro-UK has been widely used to treat myocardial infarction in China. Since 2016, we carried a phase 2 clinical trial to explore the dosing of rhPro-UK in patients with acute ischemic stroke, followed by another study with a sample size of 680 patients to initially validate the efficacy and safety of the proposed dose of 35mg. The results of these studies suggested that rhPro-UK was effective, and there were no safety concerns. To further prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, we conducted this phase 3 study (PROST-2).

NCT ID: NCT05700266 Not yet recruiting - Ischemic Stroke Clinical Trials

Anticoagulant Using Rivaroxaban on Top of Aspirin Versus Antiplatelet Therapy in Intracranial Atherostenosis Stenosis

AA-ICAS
Start date: March 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack (TIA) caused by intracranial artery stenosis. Participants will be divided into 2 groups to receive either oral rivaroxaban plus aspirin or oral clopidogrel plus aspirin. The main question it aims to answer is whether the experimental group (oral rivaroxaban plus aspirin) is superior to the control group ( oral clopidogrel plus aspirin) to lower recurrent stroke/TIA or death in these patients during 1 year of follow-up.

NCT ID: NCT05697718 Not yet recruiting - Ischemic Stroke Clinical Trials

Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-S) in the Treatment of Ischemic Stroke

Start date: March 1, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of IxCellhUC-MSC-S as a single intravenous infusion in convalescent patients with ischemic stroke. To explore the efficacy of IxCellhUC-MSC-S as a single intravenous infusion in patients with convalescent ischemic stroke.

NCT ID: NCT05697575 Not yet recruiting - Acute Stroke Clinical Trials

Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

REPIN
Start date: February 1, 2023
Phase:
Study type: Observational [Patient Registry]

The study will collect data from aged 18 to 85 years with a diagnosis of acute stroke, who received thrombolytic treatment with a new agent, nonimmunogenic staphylokinase. Outcomes will be checked for safety and compared to the results of treatment with the other thrombolytic drug, alteplase.

NCT ID: NCT05697185 Not yet recruiting - Clinical trials for Ischemic Stroke, Acute

Safety and Efficacy of Evolocumab in Ischemic Stroke

SEEIS
Start date: February 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).