Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment (DICAST-SF)

General University Hospital, Prague

Status

Completed

Conditions

Stroke

Treatments

Device: Soterix Medical 1X1 tDCS stimulator (active C-tDCS)

Device: Soterix Medical 1X1 tDCS stimulator (sham stimulation)

Study type

Interventional

Funder types

Other

Identifiers

NCT04801446

1786/20 S-IV

Details and patient eligibility

About

This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for endovascular therapy (EVT). Patients will be randomized in a 3:1 design, to cathodal versus sham (control) tDCS, 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.