Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · May 31, 2024

Keywords

ClinConnect Summary

This multi-site, phase 2a, randomized, sham-controlled, adaptive study aims to identify an optimal dose of a new treatment, cathodal direct current stimulation or C-tDCS, for acute ischemic stroke. This new treatment involves applying a weak inhibitory electrical current to the brain via scalp electrodes in acute stroke patients. The weak electrical current will electrically protect the brain cells not receiving enough oxygen and nutrients due to blood vessel blockage and increase the collateral blood flow to the brain.

The study primarily aims to find an optimal dose that shows adequate s...

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Eligibility criteria

• 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)
• • 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 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.
• • 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