The goal of this clinical trial is to evaluate whether low-frequency, low-intensity transcranial magnetic stimulation (ELF-MF), delivered by the I-NIC medical device, is effective and safe in treating patients with acute ischemic stroke.
The study aims to answer the following questions:
Does ELF-MF stimulation with the I-NIC device improve outcomes in patients with acute cerebral ischemia? Is the treatment safe and well tolerated?
Researchers will compare the I-NIC device to a placebo device (identical in appearance but without active stimulation), both in addition to standard care, to determine its effectiveness.
Participants will:
* Be randomly assigned to receive either standard care plus I-NIC treatment or standard care plus a placebo device
* Start treatment within 48 hours of symptom onset
* Receive daily treatment sessions of 120 minutes for 5 consecutive days
* Undergo clinical and neurological evaluations at baseline, 7 days, and 90 days (the 90-day visit may be conducted remotely)
* Provide clinical and demographic data during the study
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study involving 364 patients across 14 centers in Italy, with a total study duration of 3 months per participant.