Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06440707
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Apr 2026
Primary completion
Jan 1, 2030
Completion
Aug 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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
    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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California- Los Angeles (UCLA)Los AngelesCalifornia90095
Mersedeh Bahr Hosseini, MD
[email protected]
310-794-6379
Jeffrey L Saver, MD
[email protected]
310-794-6379
Johns Hopkins Medical CenterBaltimoreMaryland21287
Argye E Hillis, MD
[email protected]
(443) 287-4610
Melissa Stockbridge, PhD
[email protected]
Argye Hillis, MD (PRINCIPAL_INVESTIGATOR)
Duke Medical Center HospitalDurhamNorth Carolina27710
Wayne Feng, MD
[email protected]
919-660-4195
Salman Ikramuddin, MD
[email protected]
919-255-0870
Wayne Feng, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of California- Los Angeles (UCLA)· Los Angeles, CAJohns Hopkins Medical Center· Baltimore, MDDuke Medical Center Hospital· Durham, NC

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