Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke
Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2
University of California, Los Angeles
120 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria12
- 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 ineligible for IV lytics per American Heart/American Stroke Associations National Guidelines
- Patient eligible for tPA per Guidelines
- Within 2-hours from intravenous thrombolytic start of administration
Exclusion Criteria28
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The active study treatment involves delivering a weak form of electrical stimulation via 5 small electrodes to the brain tissue at risk of infarction.
Sham patients will have cap and electrodes in place, but no stimulation will be delivered.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06440707