Los Angeles, California 90095


Purpose:

This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for intravenous thrombolysis and endovascular therapy.


Study summary:

This is a single center, sham-controlled, dose escalation study where cathodal tDCS is delivered to threatened but not yet irreversibly damaged (penumbral) tissue in patients with large vessel occlusion who are not eligible for blood flow restoring recanalization procedures. Patients will be randomized in a 3:1 design, to cathodal versus sham (control) stimulation, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.


Criteria:

Inclusion criteria: 1. New focal neurologic deficit consistent with AIS 2. NIHSS≥4; 3. Age>18; 4. ICA or M1 or M2 MCA occlusion on MRA; 5. Presence of a perfusion (PWI)-ischemic core (DWI) mismatch ratio ≥ 1.2; 6. Patient ineligible for IV tPA, per national AHA/ASA Guidelines 7. Patient ineligible for endovascular therapy per AHA/ASA national Guidelines - one or more of: poor prestroke functional status (mRS score >1), mild neurological symptoms (NIHSS <6), large ischemic core (ASPECTS <6), thrombectomy not technically performable due to severe vessel tortuosity, cervical artery chronic occlusion, or other unfavorable angioarchitectural features that preclude endovascular access to the target intracranial vessel. 8) Subject is able to be treated with tDCS within 24 hours of last known well time; 9) A signed informed consent is obtained from the patient or patient's legally authorized representative Exclusion criteria 1. Acute intracranial hemorrhage 2. Ischemic core volume (ADC≤ 620 µm2/s) ≥ 100 ml 3. Presence of MRI/tDCS contraindications - electrically or magnetically activated metal and non-metal implants, such as a cardiac pacemaker 4. Severe MR contrast allergy or renal dysfunction with eGFR<30ml/min, precluding MRI gadolinium 5. Pregnancy 6. Signs or symptoms of acute myocardial infarction, including EKG findings, on admission 7. Suspicion of aortic dissection on admission 8. History of seizure disorder or new seizures with presentation of current stroke 9. 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 10. Concomitant experimental therapy 11. Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow pattern)


NCT ID:

NCT03574038


Primary Contact:

Principal Investigator
Mersedeh Bahr Hosseini, MD
University of California, Los Angeles

Mersedeh Bahr Hosseini, MD
Phone: 310-794-6379
Email: mbahrhosseini@mednet.ucla.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States

Mersedeh Bahr Hosseini, M.D.
Phone: 310-794-1195
Email: mbahrhosseini@mednet.ucla.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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