Status:
TERMINATED
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
The City College of New York
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 occlusi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- New focal neurologic deficit consistent with AIS
- Age≥18
- NIHSS ≥ 4
- ICA or M1 or M2 MCA occlusion on pre-thrombectomy MRA or CTA
- Onset (last-seen-well) time to randomization time within 24 hours
- Pre-stroke modified Rankin Scale≤ 3.
- Patient ineligible for IV tPA, per national AHA/ASA Guidelines.
- Having undergone endovascular thrombectomy with less than a complete reperfusion (\<TICI 2c, 3) for receiving post-thrombectomy adjunct C-tDCS.
- Undergoing endovascular thrombectomy, per national AHA/ASA Guidelines for patients who are assigned to pre-thrombectomy bridging session at Tiers 5, 6.
- A signed informed consent is obtained from the patient or patient's legally authorized representative
- Exclusion criteria
- Acute intracranial hemorrhage
- Evidence of a large Ischemic core volume (ADC \< 620 µm2/s or rCBF\< 30%) ≥ 100 ml
- Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
- 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, consist of a platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.
Exclusion
Key Trial Info
Start Date :
July 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04061577
Start Date
July 28 2019
End Date
April 1 2022
Last Update
July 20 2023
Active Locations (1)
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1
University of California- Los Angeles (UCLA)
Los Angeles, California, United States, 90095