Status:
COMPLETED
Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment
Lead Sponsor:
General University Hospital, Prague
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimu...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- New focal neurologic deficit consistent with acute ischemic stroke.
- Baseline NIHSS ≥ 4 or NIHSS \< 4 in the presence of disabling deficits (e.g. aphasia)
- Presence of acute occlusion of ICA or MCA (including MCA peripheral cortical branches) according to clinical picture and baseline CTA/CTP scan.
- Presence of salvageable penumbra with Tmax \> 6 sec/ ischemic core volume (rCBF \< 30%) ≥ 1.2 on baseline CTP scan.
- Patient is ineligible for EVT per current national guidelines (Cerebrovascular Section of Czech Neurological Society ČLS JEP).
- Subject 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 (point 30 of Declaration of Helsinki).
Exclusion
- Acute intracranial hemorrhage including suspected subarachnoid hemorrhage.
- Other than ischemic cause of acute neurological deficit (stroke mimics:postparoxysmal Todd´s palsy, metabolic cause, tumor, meningoencephalitis etc.).
- Evidence of a large Ischemic core volume on baseline CTP: volume of rCBF\<30% ≥ 100ml.
- Subacute or chronic subdural hematoma or hygroma.
- Intra-axial malignant brain tumor.
- History of spontaneous ICH in the past.
- History of seizure disorder or new seizures with presentation of current stroke.
- History of intracranial surgery.
- Presence of tDCS contraindications: skin lesion at the site of stimulation (open wound, acute inflammation of skin or subcutaneous tissue, burns etc.); skull defect at the site of stimulation (e.g. skull fracture, postcraniectomy); implanted electric device (pacemaker, ICD, DBS, cochlear implant etc.); presence of metal material in head (e.g. metal stent, clamps etc.).
- Thrombocytopenia \< 100 000/ul.
- INR \> 3,0.
- Heparin or LMWH therapy in last 48 hours with aPTT increased more than 1,5 times over limit of the laboratory.
- History of acute overdose by DOAC.
- Known congenital or acquired increased bleeding propensity.
- Suspected or confirmed pregnancy.
- Known CT iodine contrast allergy.
- Known renal dysfunction (eGFR\<30 ml/min.).
- Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
- Suspicion of aortic dissection on admission.
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04801446
Start Date
May 10 2021
End Date
February 10 2024
Last Update
August 6 2024
Active Locations (1)
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1
Department of Neurology, General University Hospital in Prague
Prague, Czechia, 12000