Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

NCT06440707 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: 24-0007801UG3NS134619-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

Cytoprotection; Collateral enhancement

Outcome Measures

Primary Outcomes (2)

• Presence of Radiographic Intracranial Hemorrhage

  Presence of any intracranial hemorrhage on brain MRI, including hemorrhagic infarction types 1,2 and parenchymal hematoma types 1 and 2.

  At 24-30 hour post-stimulation

• Presence of Substantial Penumbra Salvage

  Presence of substantial penumbra salvage on hemodynamic brain MRI is defined as the presence of salvage of more than equal to 40% of penumbra.

  At 24-30 hour post-stimulation

Secondary Outcomes (8)

• Frequency of Symptomatic Intracranial Hemorrhage-Safety Outcome

  At 24-30 hour post-stimulation

• Frequency of Early Neurologic Deterioration-Safety Outcome

  At 24-hour post-stimulation

• All-cause Mortality -Safety Outcome

  At day 90 post-stimulation

• Frequency of Completion of Stimulation Protocol-Tolerability Outcome

  At the end of each 20 minute stimulation period

• Frequency and Severity of Adverse Events-Tolerability Outcome

  At the end of each 20 minute stimulation period

Other Outcomes (5)

• Effect of Treatment on Rate of Intracranial Hemorrhage-Exploratory Efficacy Outcome

  At 24-30 hour post-stimulation

• Effect of Treatment on Rate of Penumbral Salvage-Exploratory Efficacy Outcome

  At 24-30 hour post-stimulation

• Early Neurological Improvement-Exploratory Early Clinical Efficacy Outcome

  At 24-hour post-stimulation

Study Arms (4)

Transcranial Direct Current Stimulation in patients ineligible for intravenous thrombolytic

ACTIVE COMPARATOR

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.

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

Sham stimulation in patients ineligible for intravenous thrombolytic

SHAM COMPARATOR

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

Device: Sham tDCS

Transcranial Direct Current Stimulation in patients receiving intravenous thrombolytic

ACTIVE COMPARATOR

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.

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

Sham stimulation in patients receiving intravenous thrombolytic

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

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

The active study treatment involves delivering a weak form of electrical stimulation via 5 small electrodes to the brain tissue at risk of infarction.

Transcranial Direct Current Stimulation in patients ineligible for intravenous thrombolytic; Transcranial Direct Current Stimulation in patients receiving intravenous thrombolytic

Sham tDCS DEVICE

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

Sham stimulation in patients ineligible for intravenous thrombolytic; Sham stimulation in patients receiving intravenous thrombolytic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ineligible for IV lytics per American Heart/American Stroke Associations National Guidelines
• Patient eligible for tPA per Guidelines
• Within 2-hours from intravenous thrombolytic start of administration

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of California, Los Angeles: lead
• Johns Hopkins University: collaborator
• Duke University: collaborator
• Cedars-Sinai Medical Center: collaborator
• University of California, San Francisco: collaborator

Study Sites (3)

University of California- Los Angeles (UCLA)

Los Angeles, California, 90095, United States

RECRUITING

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

RECRUITING

Duke Medical Center Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mersedeh Bahr-Hosseini, MD

CONTACT

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

Jeffrey Saver, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: Adaptive Bayesian Design

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 4, 2024
• Study Start: July 15, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (3)