Recruiting

Phase 2

Electrical StimulationTranscranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

Sponsor:

UCLA

Code:

NCT06440707

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)

Sham tDCS

Study Details

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.

Conditions

Acute Ischemic Stroke

Study ID

NCT06440707

Start date

Jul 15, 2025

Status verified date

Apr, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Transcranial Direct Current Stimulation in patients ineligible for intravenous thrombolytic

Patients in the active stimulation group receive cathodal transcranial electrical stimulation via 5 small electrodes for 20 to 60 minutes (min) at 1 or 2 milliamperes (mA) intensities. The duration and intensity of the stimulation will determined by the dose Tier the patient is assigned to. There will be 5 dose tiers, reflecting increasing intensity and duration of stimulation: Tier1- 2 mA, single 20 min cycle; Tier 2 - 1 mA, 2 cycles of 20 min/20 min off; Tier 3- 2mA, 2 cycles of 20 min/20 min off; Tier 4 - 1 mA, 3 cycles of 20min/20 min off; Tier 5 - 2 mA, 3 cycles of 20 min/20 min off.

The decision to which dose Tier the patient should be assigned will be determined by the mathematical Bayesian model.

sham comparator: Sham stimulation in patients ineligible for intravenous thrombolytic

Patients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation.

active comparator: Transcranial Direct Current Stimulation in patients receiving intravenous thrombolytic

sham comparator: Sham stimulation in patients receiving intravenous thrombolytic

Patients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation.

Interventions

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.

Sham tDCS

Sham patients will have cap and electrodes in place, but no stimulation will be delivered.

Primary outcome measure

Presence of Radiographic Intracranial Hemorrhage [ Time Frame: At 24-30 hour post-stimulation ]
Presence of Substantial Penumbra Salvage [ Time Frame: At 24-30 hour post-stimulation ]

Central Contacts and Locations

Central contacts

Mersedeh Bahr-Hosseini, MD

310-794-1195 MBahrHosseini@mednet.ucla.edu

Jeffrey Saver, MD

310-794-1195 jsaver@mednet.ucla.edu

Locations

University of California- Los Angeles (UCLA)

Recruiting

Los Angeles, California, United States, 90095

Contacts

Mersedeh Bahr Hosseini, MD

310-794-6379 mbahrhosseini@mednet.ucla.edu

Jeffrey L Saver, MD

310-794-6379 jsaver@mednet.ucla.edu

Johns Hopkins Medical Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Argye E Hillis, MD

(443) 287-4610 argye@jhmi.edu

Melissa Stockbridge, PhD

md.stockbridge@jhmi.edu

Principal Investigator:

Argye Hillis, MD

Duke Medical Center Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Wayne Feng, MD

919-660-4195 wayne.feng@duke.edu

Salman Ikramuddin, MD

919-255-0870 salman.ikramuddin@duke.edu

Principal Investigator:

Wayne Feng, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

Cytoprotection
Collateral enhancement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-01.