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Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy

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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 with substantial salvageable penumbra due to a large vessel occlusion before and after endovascular therapy.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

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Study Stats
Protocol No.
19-000529
Category
Neurology
Urology
Principal Investigator
MERSEDEH BAHRHOSSEINI
Contact
Gilda Avila
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04061577
For detailed technical eligibility, visit ClinicalTrials.gov.