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Neuroprotection in Acute Cerebral Ischemia II
Sponsor: IGEA
Summary
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.
Official title: Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of I-NIC Therapy in Patients With Acute Ischemic Stroke.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2026-06-15
Completion Date
2029-09-15
Last Updated
2026-04-27
Healthy Volunteers
No
Conditions
Interventions
Treatment with the I-NIC medical device for neuroprotection
Treatment with low-frequency, low-intensity transcranial magnetic stimulation (ELF-MF) administered using the I-NIC medical device.
Treatment with I-NIC sham device
The sham I-NIC device will be connected to a sham solenoid identical to the active solenoid but not emitting any electromagnetic field