NCT07552818Not yet recruiting
Neuroprotection in Acute Cerebral Ischemia II
Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of I-NIC Therapy in Patients With Acute Ischemic Stroke.
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 364 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 15 Jun 2029
- Lead sponsor
- IGEA
- Diseases
- Stroke
- NCT number
- NCT07552818
What you commit to
- Study type: Interventional
- Planned participants: 364
- From 15 Jun 2026 to the primary completion date, 15 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ischemic or hemorrhagic stroke with residual mRS \> 1
- Ongoing treatment with anti-glutamatergic drugs: memantine, ketamine, and lamotrigine
Other illness
- Pre-stroke modified Rankin Scale (mRS) \> 1
- Other severe or complex conditions that may confound the evaluation of the treatment
- Diagnosis of lacunar syndrome
- History of epilepsy or occurrence of seizures in the acute post-stroke phase
- Presence of symptomatic intracranial hemorrhage. For asymptomatic hemorrhagic transformations, the SITS-MOST classification will be used:
- HI 1: small petechiae along the margins of the infarct HI 2: more confluent petechiae within the infarct area without space-occupying effect PH 1: blood clot(s) not exceeding 30% of the infarct area with mild space-occupying effect PH 2: blood clots exceeding 30% of the infarct area with significant space-occupying effect PHr 1: small or medium-sized blood clots located remote from the infarct, possibly with mild space-occupying effect PHr 2: large confluent dense blood clots remote from the infarct, with significant space-occupying effect.
- Only patients classified as HI1 and HI2 may be enrolled, at the investigator's discretion. Patients classified as PH1, PH2, PHr1, or PHr2 will be excluded from the study.
Other
- Pregnant or breastfeeding women, or women with a positive or indeterminate pregnancy test; women of childbearing potential who cannot exclude the possibility of pregnancy
- Undergoing decompressive craniectomy
- Current participation in other interventional clinical studies
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.