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Not yet recruitingNCT07552818Updated Apr 27, 2026

Neuroprotection in Acute Cerebral Ischemia II

An interventional study of Treatment with the I-NIC medical device for neuroprotection and Treatment with I-NIC sham device in Acute Ischemic Stroke, sponsored by IGEA. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by IGEA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
364
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 364 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

IGEA is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
364 participants (estimated)

Study arms

  • Active comparator
    Treatment with the I-NIC medical device for neuroprotection

    Device: Treatment with the I-NIC medical device for neuroprotection

  • Sham comparator
    Treatment with the I-NIC medical device sham

    Device: Treatment with I-NIC sham device

Interventions

  • DeviceTreatment 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.

  • DeviceTreatment 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

06

What researchers measure

Primary outcomes

  1. Modified Rankin Scale (mRS)

    Percentage of patients achieving an excellent outcome mRS = 0-1

    Time frame: 90 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Psychogios M, Brehm A, Ribo M, Rizzo F, Strbian D, Raty S, Arenillas JF, Martinez-Galdamez M, Hajdu SD, Michel P, Gralla J, Piechowiak EI, Kaiser DPO, Puetz V, Van den Bergh F, De Raedt S, Bellante F, Dusart A, Hellstern V, Khanafer A, Parrilla G, Morales A, Kirschke JS, Wunderlich S, Fiehler J, Thomalla G, Lemmens R, Peluso JP, Bolognese M, von Hessling A, van Es A, Kruyt ND, Coutinho JM, Castano C, Minnerup J, van Zwam W, Dhondt E, Nolte CH, Machi P, Loehr C, Mattle HP, Buhk JH, Kaesmacher J, Dobrocky T, Papanagiotou P, Alonso A, Holtmannspoetter M, Zini A, Renieri L, Keil F, van den Wijngaard I, Kagi G, Terceno M, Wiesmann M, Amaro S, Rommers N, Balmer L, Fragata I, Katan M, Leker RR, Saver JL, Staals J, Fischer U; DISTAL Investigators. Endovascular Treatment for Stroke Due to Occlusion of Medium or Distal Vessels. N Engl J Med. 2025 Apr 10;392(14):1374-1384. doi: 10.1056/NEJMoa2408954. Epub 2025 Feb 5. PubMed 39908430 ↗
  • Capone F, Liberti M, Apollonio F, Camera F, Setti S, Cadossi R, Quattrocchi CC, Di Lazzaro V. An open-label, one-arm, dose-escalation study to evaluate safety and tolerability of extremely low frequency magnetic fields in acute ischemic stroke. Sci Rep. 2017 Sep 22;7(1):12145. doi: 10.1038/s41598-017-12371-x. PubMed 28939890 ↗
  • Capone F, Dileone M, Profice P, Pilato F, Musumeci G, Minicuci G, Ranieri F, Cadossi R, Setti S, Tonali PA, Di Lazzaro V. Does exposure to extremely low frequency magnetic fields produce functional changes in human brain? J Neural Transm (Vienna). 2009 Mar;116(3):257-65. doi: 10.1007/s00702-009-0184-2. Epub 2009 Feb 3. PubMed 19189041 ↗
  • Grant G, Cadossi R, Steinberg G. Protection against focal cerebral ischemia following exposure to a pulsed electromagnetic field. Bioelectromagnetics. 1994;15(3):205-16. doi: 10.1002/bem.2250150305. PubMed 8074737 ↗
  • Capone F, Salati S, Vincenzi F, Liberti M, Aicardi G, Apollonio F, Varani K, Cadossi R, Di Lazzaro V. Pulsed Electromagnetic Fields: A Novel Attractive Therapeutic Opportunity for Neuroprotection After Acute Cerebral Ischemia. Neuromodulation. 2022 Dec;25(8):1240-1247. doi: 10.1111/ner.13489. Epub 2022 Feb 2. PubMed 34480781 ↗
  • Varani K, Gessi S, Merighi S, Iannotta V, Cattabriga E, Spisani S, Cadossi R, Borea PA. Effect of low frequency electromagnetic fields on A2A adenosine receptors in human neutrophils. Br J Pharmacol. 2002 May;136(1):57-66. doi: 10.1038/sj.bjp.0704695. PubMed 11976268 ↗
  • Capone F, Zini A, Valzania F, Diomedi M, Tugnoli V, Leocani L, Comi G, Anzalone N, Contardi S, Colella M, Liberti M, Salati S, Setti S, Cadossi R, Di Lazzaro V. Neuroprotective Effects of Pulsed Electromagnetic Fields in Acute Stroke. J Stroke. 2024 Sep;26(3):458-462. doi: 10.5853/jos.2024.01529. Epub 2024 Sep 27. No abstract available. PubMed 39326864 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07552818
Lead sponsor
IGEA
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Jun 15, 2029 (estimated)
Completion
Sep 15, 2029 (estimated)
Last update
Apr 27, 2026

Study contacts

Simona Salati
Contact
s.salati@igeamedical.com
0039059699600
Michela Battista
Contact
m.battista@igeamedical.com
00393471260925

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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