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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
364
Treatment with low-frequency, low-intensity transcranial magnetic stimulation (ELF-MF) administered using the I-NIC medical device.
The sham I-NIC device will be connected to a sham solenoid identical to the active solenoid but not emitting any electromagnetic field
Modified Rankin Scale (mRS)
Percentage of patients achieving an excellent outcome mRS = 0-1
Time frame: 90 days
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