Neuroprotection in Acute Cerebral Ischemia II

April 20, 2026 updated by: IGEA

Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of I-NIC Therapy in Patients With Acute Ischemic Stroke.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment with the I-NIC medical device for neuroprotection
Device: 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.
Sham Comparator: Treatment with the I-NIC medical device sham
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: 90 days
Percentage of patients achieving an excellent outcome mRS = 0-1
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IGEA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

September 15, 2029

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-NIC 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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