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.
• 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