RECRUITING

Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

Conditions

Acute Ischemic Stroke Cytoprotection Collateral enhancement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2

Quick Facts

Study Start:2025-08-01

Study Completion:2030-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06440707

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Mersedeh Bahr-Hosseini, MD

CONTACT

310-794-1195

MBahrHosseini@mednet.ucla.edu

Jeffrey Saver, MD

CONTACT

310-794-1195

jsaver@mednet.ucla.edu

Study Locations (Sites)

University of California- Los Angeles (UCLA)

Los Angeles, California, 90095

United States

Johns Hopkins Medical Center

Baltimore, Maryland, 21287

United States

Duke Medical Center Hospital

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2030-08-01

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2030-08-01

Terms related to this study

Keywords Provided by Researchers

Cytoprotection
Collateral enhancement

Additional Relevant MeSH Terms

Acute Ischemic Stroke