Weak Electrical Current Tested for Acute Stroke Brain Tissue Rescue

Trial details

Who runs it

University of California, Los Angeles

Trial code

NCT06440707

Record updated

1 May 2026

Original description

Many patients with acute ischemic stroke are ineligible for currently available standard treatments (clot-busting medication, also known as intravenous thrombolytic or mechanical removal of a clot), and many are non-responders, resulting in a low rate of excellent outcomes, which necessitates the development of novel therapies.Read full original descriptionShow less

Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2

Many patients with acute ischemic stroke are ineligible for currently available standard treatments (clot-busting medication, also known as intravenous thrombolytic or mechanical removal of a clot), and many are non-responders, resulting in a low rate of excellent outcomes, which necessitates the development of novel therapies.

In this study, investigators are testing a new treatment in which a weak electrical current will be applied via scalp electrodes to increase collateral blood flow to the brain and rescue the brain tissue at risk of injury. The primary aim is to find an optimal dose of this therapy that is both adequately safe and effective on imaging markers of brain tissue rescue.

Inclusion: New focal neurologic deficit consistent with AIS; National Institute of Health Stroke Scale (NIHSS) ≥4 or NIHSS< 4 in the presence of disabling deficit (a deficit that, if unchanged, would prevent the; patient from performing basic activities of daily living such as bathing, ambulating, toileting, hygiene, and eating or returning to work); Age>18; Presence of any cortical vessel occlusion, including Internal Carotid Artery, branches of Middle Cerebral Artery, Anterior Cerebral Artery, Posterior Cerebral Artery, Posterior-Inferior Cerebellar Artery; Presence of salvageable penumbra with perfusion lesion volume to ischemic core volume ratio of ≥ 1.2 on multimodal imaging; Patient ineligible for endovascular thrombectomy per American Heart/Stroke Associations Guidelines; Patient is able to be treated with tDCS within 24 hours of last known well time; A signed informed consent is obtained from the patient or patient's legally authorized representative; Additional inclusion criteria for non-thrombolytic patients; Patient ineligible for IV lytics per American Heart/American Stroke Associations National Guidelines; Additional inclusion criteria for thrombolytic receiving patients; Patient eligible for tPA per Guidelines; Within 2-hours from intravenous thrombolytic start of administration.

Exclusion: Presence of transcranial direct current stimulation contraindications - electrically or magnetically activated intracranial metal and non-metal implants; Concomitant experimental therapy; Patient with radiographic evidence or suspicion of chronic conditions that may predispose them to intracranial hemorrhage, including brain arteriovenous malformations, cerebral cavernous malformations, cerebral telangiectasia, multiple previous intracerebral hemorrhages (amyloid angiopathy); Acute intracranial hemorrhage; Presence of MRI and gadolinium contraindications including cardiac implantable devices, cochlear implant, implanted neurostimulation device, unremovable metallic body piercing, magnetic dental implants, drug infusion pumps, estimated glomerular filtration rate of less than 35 mL/min/1.73 m2, allergy to gadolinium; Signs or symptoms of acute myocardial infarction on admission; History of seizure disorder or new seizures with presentation of current stroke; Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, including attendance at the 3-month follow-up visit; Patients suspected of having infective endocarditis and ischemic stroke related to septic emboli; Patients suspected or known to be infected with coronavirus 2019 (COVID-19); Suspected cranial dural arteriovenous fistula; Cerebral venous thrombosis; Patient has suffered a hemorrhagic or ischemic stroke within the last three (3) months; History of cancer known to cause hemorrhagic metastases, e.g., melanoma, renal cell carcinoma,; History of left atrial myxoma; Evidence of a large Ischemic core volume more than equal to 100 cc; Pregnancy; Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow; pattern); Preexisting coagulopathy; Suspected cerebral vasculitis based on medical history and imaging; Suspected cysticercosis; Head trauma causing loss of consciousness, concussion, confusion, or a headache within the past 30 days; choriocarcinoma, thyroid carcinoma, lung carcinoma, breast carcinoma, and hepatocellular carcinoma; Evidence of dissection in the intracranial cerebral arteries; Suspicion of aortic dissection; Significant mass effect with midline shift; The patient is in a coma.

ClinicalTrials.gov NCT06440707