Clinical Research Directory

Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke: A Sham-Controlled Trial

The goal of this clinical trial is to evaluate the efficacy of a 5-day short-course external trigeminal nerve stimulation (eTNS) regimen in patients with acute ischemic stroke. The main questions it aims to answer are whether a 5-day eTNS intervention can significantly improve the neurological response rate at Day 30 compared to sham stimulation, and whether this short-course treatment yields sustained improvements in neuropsychiatric symptoms (depression, anxiety, and insomnia) over a 90-day follow-up period. Researchers will compare the active eTNS group to a sham-controlled group to see if the 5-day stimulation provides a sustained neuroprotective effect. Participants will be randomly assigned (1:1) to receive either active eTNS or sham eTNS for 5 consecutive nights within 72 hours of stroke onset, in addition to standard medical therapy, and will undergo neurological and functional assessments (NIHSS, mRS, BI) at baseline (Day 0), Day 5, Day 30, Day 60, and Day 90, as well as complete neuropsychiatric questionnaires (PHQ-9, GAD-7, and ISI) during the follow-up visits to evaluate their mood and sleep quality. In addition, brain imaging data and blood samples will be collected at baseline (Day 0) and after the 5-day intervention (Day 5) for exploratory analyses of infarct volume and peripheral inflammatory markers.

THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing

The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.

ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke

This study will evaluate the safety and feasibility of administering umbilical cord-derived mesenchymal stromal cells (UC-MSCs) following mechanical thrombectomy in adults with acute ischemic stroke. Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain, potentially causing brain tissue damage and neurological impairment. The study will include 10 adults aged 18 to 70 years. All participants will receive standard stroke care, including mechanical thrombectomy to remove the blood clot. Participants will be randomly assigned to one of two groups. One group will receive standard care plus a single dose of 20 million UC-MSCs derived from donated umbilical cord tissue. The cells will be delivered through a microcatheter into the artery supplying the affected part of the brain. The other group will receive standard care without the cell treatment. Both groups will receive physical rehabilitation. Researchers will follow participants for six months. They will monitor health problems and assess recovery, disability, blood markers, and brain scans. The main goal is to determine whether this treatment can be administered safely and feasibly. It is not yet known whether the treatment will improve recovery after stroke.

Tenecteplase Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours

This multicenter, randomized clinical trial will assess whether intravenous tenecteplase given before interhospital transfer improves outcomes compared with direct transfer without tenecteplase. Eligible participants are adults with acute ischemic stroke caused by occlusion of the M1 segment or proximal dominant M2 segment of the middle cerebral artery, more than 4.5 hours and no more than 24 hours after symptom onset or the last known well time. Participants will be assigned in a 1:1 ratio to receive tenecteplase before transfer or to undergo direct transfer without study-related intravenous thrombolysis. At the receiving stroke center, both groups will be evaluated for endovascular therapy and treated when clinically indicated. The primary outcome is the proportion of participants with a modified Rankin Scale score of 0-2 at 90 days after randomization. The study will also assess neurological improvement, vessel reopening, intracranial hemorrhage, and other clinical outcomes.

Metformin in Acute Ischemic Stroke

The goal of this clinical trial is to study the efficacy of oral Metformin in Acute Ischemic Stroke (AIS). The main hypothesis is to study the efficacy of oral Metformin in patients with acute ischemic stroke presenting within 72 hours of onset in terms of goof modified Rankin scale (mRS) at 90 days. Researchers will compare placebo tablets. Participants will randomised to Metformin or placebo in 1:1 ratio. Additionally, the blood sample will be collected to look for biomarkers hsCRP, Vitamin B12, and Holotranscobalamin at baseline and follow-up.

Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2

This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.

Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke

This study will examine the short-term safety and tolerability of NRICM301, a food-grade herbal formula also known as Taiwan Xingnao No. 1, when added to standard care for adults hospitalized with acute ischemic stroke. An ischemic stroke occurs when blood flow to part of the brain is blocked. The study will enroll up to 45 adults at Tri-Service General Hospital in Taiwan. Participants will be randomly assigned to receive either NRICM301 or a matching placebo for 14 days. Both groups will continue to receive standard stroke care. The study drink will be given by mouth or through a nasogastric tube, starting within 24 hours after hospital arrival. Participants and the study personnel involved in treatment and assessments will not know which study product each participant receives. The main question is whether the proportion of participants who experience an adverse event considered at least possibly related to the study product differs between the two groups through Day 15. The study will also assess blood test results, neurological function, ability to perform daily activities, hospital and intensive care use, and inflammation markers. Follow-up is planned through Day 91. This is an exploratory safety study; it is not designed to establish definitive treatment effectiveness.

FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions

The objective of this study is to collect safety and effectiveness data on the Penumbra System reperfusion catheters in participants with isolated primary non-dominant and distal M2 occlusions who undergo endovascular mechanical thrombectomy (EVT). Additionally, this study aims to observe characteristics and outcomes of participants treated with medical management (MM) alone and those who receive EVT + MM per current medical practice.

Sevoflurane vs. Propofol for General Anesthesia in Patients With Acute Ischemic Stroke Treated With Endovascular Therapy

Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. Patients with this condition may require endovascular therapy, a procedure used to remove the clot and restore blood flow. General anesthesia is sometimes needed during this procedure. The SAVE trial compares two medicines used for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy: sevoflurane and propofol. The aim of the study is to determine whether the choice of anesthetic medicine affects the final volume of brain tissue damaged by the stroke. Participants will be randomly assigned to receive either sevoflurane or propofol during general anesthesia. The final volume of the brain infarction will be assessed using magnetic resonance imaging (MRI) approximately 72 hours after treatment. Participants will also be followed for up to 90 days to assess their clinical outcomes. The study plans to include 314 participants across seven hospitals in Spain. The results may help improve understanding of how the choice of anesthetic medicine affects outcomes in patients with acute ischemic stroke treated with endovascular therapy.

Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence

This multicenter, prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke treated more than 4.5 hours and up to 24 hours after stroke onset, selected using a noncontrast computed tomography-based artificial intelligence (CT-AI) tissue-window algorithm. A total of 826 participants will be randomly assigned in a 1:1 ratio to receive intravenous rhPro-UK or matching placebo, in addition to guideline-recommended standard stroke care. The primary outcome is the proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days. Secondary outcomes include functional outcomes, changes in neurological deficits, early neurological improvement at 24 hours and 7 days, and tissue reperfusion at 24-48 hours. Safety outcomes include symptomatic intracranial hemorrhage, parenchymal hematoma, all-cause mortality, and serious systemic bleeding.

Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke

Acute ischemic stroke occurs when blood flow to part of the brain is blocked. This study will assess the safety and feasibility of adding NRICM301, a food-grade formula also called Taiwan Xingnao No. 1, to usual care for adults with acute ischemic stroke. The study plans to enroll 45 participants at En Chu Kong Hospital in Taiwan. Participants will be assigned by chance in a 1:1 ratio to receive NRICM301 or a similar-looking placebo drink for 14 days, in addition to usual stroke care. Each dose is 100 mL, taken twice daily by mouth or through a nasogastric feeding tube. The first dose will be given within 24 hours after arrival at the hospital. Participants and study personnel who assess outcomes will not know which drink participants receive. The main question is whether the proportion of participants experiencing adverse events differs between the two groups from the first dose through the 90-day follow-up visit. Blood tests, stroke severity, disability, ability to perform daily activities, hospital and intensive care use, and inflammatory markers will also be evaluated. This exploratory study is intended to identify safety signals and estimate changes that can help plan a larger study; it is not designed to establish definitive treatment effectiveness.

Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy

The main goal of this study is to find out if a new, quick "brain rescue" procedure can help people recover better from a severe stroke caused by a large vessel occlusion. When someone has this type of stroke, doctors often perform a procedure called an endovascular thrombectomy (EVT). In EVT, they thread a thin tube through a blood vessel up to the brain to remove the clot and restore blood flow. This is a highly effective treatment. However, for some patients, suddenly restoring blood flow can cause additional, unexpected injury to the brain. This is called "reperfusion injury." This study tests a technique called rapid local ischemic postconditioning (RL-IPostC) that might prevent this extra damage. It's a very simple additional step performed immediately after the clot is successfully removed. The doctor would briefly inflate and deflate a tiny balloon inside the proximal brain artery after recanalization, creating very short, controlled "pauses" in blood flow. This is believed to give brain cells a gentler "wake-up" call, helping them tolerate the return of oxygen-rich blood. The study will test two different "doses" of this procedure (meaning different numbers of inflation/deflation cycles) against the standard care (no additional procedure). Phase IIb (the first part): Which dose of RL-IPostC (high or low) is more promising for reducing early brain swelling (measured by whether the brain's midline has shifted less than 3 mm on a 24-hour scan)? Phase III (the main part): Using the best dose from Phase IIb, does RL-IPostC improve a patient's functional recovery three months later, specifically enabling them to walk and manage daily activities without help? A total of 288 participants who have had a large-vessel occlusion stroke and successful clot removal will be enrolled. If early results look promising but not quite conclusive, the study can increase the total number of participants up to 448 to get a clearer answer. If successful, this study could identify a simple, low-cost add-on procedure to a standard stroke treatment that improves long-term recovery and quality of life for thousands of stroke patients. It's a potential new tool to protect the brain after blood flow is restored. This is a carefully designed study testing a gentle "on/off" blood flow technique right after clot removal, to see if it can reduce brain injury and help people walk and live more independently after a severe stroke.

Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)

Acute ischemic stroke may result in substantial disability despite timely reperfusion therapy because ischemic and reperfusion-related brain injury can continue before, during, and after restoration of blood flow. This investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate whether a protocolized Stimulation-Temperature-Oxygen-Positioning (STOP) multimodal neuroprotective strategy added to guideline-based reperfusion therapy and stroke-unit care improves 90-day functional outcome compared with standard care alone. A total of 380 adults with acute ischemic stroke treated with intravenous thrombolysis and/or endovascular therapy within 24 hours of symptom onset or last known well will be randomized in a 1:1 ratio to the STOP strategy plus standard care or standard care alone. The STOP strategy comprises transcutaneous auricular vagus nerve stimulation, protocolized normothermia targeting a body temperature of 37.5 °C or lower, high-flow normobaric oxygen, and dynamic head positioning according to reperfusion treatment and recanalization status. The primary outcome is the ordinal distribution of modified Rankin Scale scores at 90 days after randomization. Blinded assessors will evaluate functional outcomes, and a blinded central imaging core laboratory will adjudicate imaging outcomes. Among participants with anterior-circulation large-vessel occlusion who undergo endovascular treatment and achieve successful reperfusion (final mTICI grade 2b-3), eligible and consenting participants may enter an embedded randomized substudy comparing selective intra-arterial hypothermia with no additional intra-arterial infusion. The second randomization will occur only after successful reperfusion has been confirmed.

Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke

This study aims to test whether transcranial temporal interference stimulation (tTIs) can improve upper limb motor function in patients in the early subacute stage after acute ischemic stroke. Participants will be randomly assigned to receive either active tTIs treatment or sham stimulation. All subjects will receive routine rehabilitation. The treatment will be given once daily for 20 consecutive days. Researchers will assess upper limb motor function before treatment, during the intervention and after the treatment course to compare the effect between the two groups. Safety will also be monitored throughout the study.

A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well

This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot. The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke. Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment. Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.

Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion

This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. After blood flow has been successfully restored, 818 participants will be randomly assigned to receive either cold saline or room-temperature saline through an artery. The main outcome is the level of disability 90 days later, measured using the modified Rankin Scale. The study will also assess safety, including bleeding in the brain and other complications.

Tenecteplase in Acute Ischemic Stroke Under Different Transfer Models

This prospective, multicenter, observational cohort study aims to evaluate the safety and effectiveness of intravenous tenecteplase (rhTNK-tPA) in patients with acute ischemic stroke managed under different transfer models. Treatment decisions are made by the treating physicians as part of routine clinical care and are not assigned by the study protocol. Clinical information, imaging findings, laboratory results, treatment data, and functional outcomes will be collected. Participants will be followed for 90 days. The primary effectiveness outcome is the modified Rankin Scale score at 90 days. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours and all-cause mortality at 90 days.

Prehospital Response and Emergency Stroke Transport Optimisation

This study aims to develop and evaluate an innovative prehospital emergency transport system for patients with acute ischemic stroke to reduce delays in reperfusion treatment. The system integrates artificial intelligence-based prehospital stroke assessment, selected examinations and blood collection in the ambulance, and real-time information sharing between emergency medical services and the receiving hospital. Its effectiveness will be evaluated in a multicenter, stepped-wedge cluster randomized controlled trial comparing the innovative system with standard prehospital care. The primary outcome is the time from hospital arrival to intravenous thrombolysis.

A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant

This is a phase II, open-label, single-arm, exploratory study to evaluate the intracranial arterial recanalization of multiple doses of LT3001 drug product in participant with acute ischemic stroke (AIS)

Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)

The aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.

Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain. The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT. Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions

The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.

Early Administration of Angong Niuhuang Pill for Disabling Acute Ischemic Stroke (EAGER Trial)

This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of early administration of Angong Niuhuang Pill in patients with disabling acute ischemic stroke. Approximately 1,200 eligible participants will be randomly assigned in a 1:1 ratio to receive Angong Niuhuang Pill or a matching placebo for 5 consecutive days. Eligible participants will be adults aged 18 to 80 years with imaging-confirmed acute ischemic stroke involving the anterior circulation, a baseline National Institutes of Health Stroke Scale (NIHSS) score of 10 to 19, symptom onset or last known well within 24 hours before randomization, and a pre-stroke modified Rankin Scale (mRS) score of 0 or 1. The primary efficacy outcome is the proportion of participants achieving functional independence at 90 days after randomization, defined as an mRS score of 0 to 2. Secondary outcomes include excellent functional outcome, the distribution of mRS scores at 90 days, change in the Barthel Index, changes in NIHSS scores, neurological improvement, and symptomatic intracranial hemorrhage. Safety outcomes include serious adverse events, all-cause mortality, and changes in hepatic and renal laboratory parameters.