RECRUITING

Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

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. 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.

Study Overview

Study Details

Study overview

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.

Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2

Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

Condition
Acute Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California- Los Angeles (UCLA), Los Angeles, California, United States, 90095

Baltimore

Johns Hopkins Medical Center, Baltimore, Maryland, United States, 21287

Durham

Duke Medical Center Hospital, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Patient eligible for tPA per Guidelines
  • * Within 2-hours from intravenous thrombolytic start of administration
  • * 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
  • * Evidence of a large Ischemic core volume more than equal to 100 cc
  • * Presence of transcranial direct current stimulation contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
  • * Pregnancy
  • * 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
  • * Concomitant experimental therapy
  • * Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow
  • * pattern)
  • * Preexisting coagulopathy
  • * 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)
  • * 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)
  • * Suspected cerebral vasculitis based on medical history and imaging
  • * Suspected cysticercosis
  • * Suspected cranial dural arteriovenous fistula
  • * Cerebral venous thrombosis
  • * Head trauma causing loss of consciousness, concussion, confusion, or a headache within the past 30 days
  • * 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,
  • * choriocarcinoma, thyroid carcinoma, lung carcinoma, breast carcinoma, and hepatocellular carcinoma
  • * History of left atrial myxoma
  • * Evidence of dissection in the intracranial cerebral arteries
  • * Suspicion of aortic dissection
  • * Significant mass effect with midline shift
  • * The patient is in a coma

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Study Record Dates

2030-08-01