NCT06440707 · University of California, Los Angeles
Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke
(TESSERACT 2)
What this study is about
Many patients with acute ischemic stroke are ineligible for currently available standard treatments (clot-busting medication, also known as given through a vein (IV) 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.
View original scientific 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.
Interventions
DEVICE
High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)
The active study treatment involves delivering a weak form of electrical stimulation via 5 small electrodes to the brain tissue at risk of infarction.
DEVICE
Sham tDCS
Sham patients will have cap and electrodes in place, but no stimulation will be delivered.
Primary outcome measures
Presence of Radiographic Intracranial Hemorrhage
Time frame: At 24-30 hour post-stimulation
Presence of any intracranial hemorrhage on brain MRI, including hemorrhagic infarction types 1,2 and parenchymal hematoma types 1 and 2.
Presence of Substantial Penumbra Salvage
Time frame: At 24-30 hour post-stimulation
Presence of substantial penumbra salvage on hemodynamic brain MRI is defined as the presence of salvage of more than equal to 40% of penumbra.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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)
- 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 criteria
- 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.
- 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
- 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
Where
- Los Angeles, California
- Baltimore, Maryland
- Durham, North Carolina
Collaborators
Johns Hopkins University, Duke University, Cedars-Sinai Medical Center, University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations