Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California- Los Angeles (UCLA)
RECRUITING
Los Angeles
Maryland
Johns Hopkins Medical Center
RECRUITING
Baltimore
North Carolina
Duke Medical Center Hospital
RECRUITING
Durham
Contact Information
Primary
Mersedeh Bahr-Hosseini, MD
MBahrHosseini@mednet.ucla.edu
310-794-1195
Backup
Jeffrey Saver, MD
jsaver@mednet.ucla.edu
310-794-1195
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 120
Treatments
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
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 receiving intravenous thrombolytic
Patients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Cedars-Sinai Medical Center, Johns Hopkins University, Duke University, University of California, San Francisco

This content was sourced from clinicaltrials.gov