Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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