Neuroprotection in Acute Cerebral Ischemia II (NCT07552818) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuroprotection in Acute Cerebral Ischemia II
364 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of ischemic stroke in the middle cerebral artery territory, confirmed by clinical evaluation by a neurologist. Baseline CT scan and follow-up CT/MRI at 12-36 hours are required
* Patients with a diagnosis of acute ischemic stroke, with symptom onset within 48 hours prior to clinical evaluation. In cases of unwitnessed onset, the time of onset is defined as the last time the patient was seen well ("last seen well")
* NIHSS score ≥ 6 at randomization (after any reperfusion treatment, if applicable)
* Written informed consent signed by the patient or legal representative.
Exclusion Criteria:
* Previous ischemic or hemorrhagic stroke with residual mRS \> 1
* Pre-stroke modified Rankin Scale (mRS) \> 1
* Other severe or complex conditions that may confound the evaluation of the treatment
* Pregnant or breastfeeding women, or women with a positive or indeterminate pregnancy test; women of childbearing potential who cannot exclude the possibility of pregnancy
* Diagnosis of lacunar syndrome
* History of epilepsy or occurrence of seizures in the acute post-stroke phase
* Ongoing treatment with anti-glutamatergic drugs: memantine, ketamine, and lamotrigine
* Undergoing decompressive craniectomy
* Current participation in other interventional clinical studies
* Presence of symptomatic intracranial hemorrhage. For asymptomatic hemorrhagic transformations, the SITS-MOST classification will be used:
HI 1: small petechiae along the margi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.