Transcranial direct current stimulation is safe and feasible in hyperacute ischemic stroke (DICAST-SF trial)

Cathodal transcranial direct current stimulation (C-tDCS) is a potential neuroprotective method in the hyperacute phase of ischemic stroke. We aimed to assess safety, tolerability, feasibility, and potential efficacy of C-tDCS in stroke patients with salvageable penumbra. DICAST-SF was a double-blind, randomized, sham-controlled (3 active: 1 sham), 3 + 3 dose-escalation trial. Inclusion criteria were stroke due to occlusion of the internal carotid or middle cerebral artery, last known well time within 24 h, substantial penumbra on CT perfusion, and ineligibility for mechanical thrombectomy. We applied C-tDCS at six dose tiers over the affected primary motor cortex. The primary safety outcome was the symptomatic intracranial hemorrhage (SICH) rate at 24 h post-stimulation. Twenty five patients were enrolled (19 active, 6 sham), mean age 81 (SD 12) years, median NIHSS 8 (IQR 6–16). No SICH occurred. Three AICH (2 post-thrombolysis) occurred in the active arm. C-tDCS was well tolerated and feasible, median randomization-to-C-tDCS start time was 8 (7–9) min. C-tDCS in hyperacute stroke was safe, well tolerated, and feasible. Findings support further evaluation in larger efficacy trials.