Acute Ischemic StrokeNCT07552818
Neuroprotection in Acute Cerebral Ischemia II
A study testing Treatment with the I-NIC medical device for neuroprotection in people with Acute Ischemic Stroke, run by IGEA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Treatment with the I-NIC medical device for neuroprotection
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Treatment with the I-NIC medical device for neuroprotection, Treatment with I-NIC sham device
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with the I-NIC medical device for neuroprotectionDevice
Treatment with low-frequency, low-intensity transcranial magnetic stimulation (ELF-MF) administered using the I-NIC medical device.
Treatment with I-NIC sham deviceDevice
The sham I-NIC device will be connected to a sham solenoid identical to the active solenoid but not emitting any electromagnetic field
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the I-NIC medical device for neuroprotection | Active comparator | Not described Receives: Device: Treatment with the I-NIC medical device for neuroprotection |
| Treatment with the I-NIC medical device sham | Sham comparator | Not described Receives: Device: Treatment with I-NIC sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Percentage of patients achieving an excellent outcome mRS = 0-1
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IGEA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552818
- Sponsor's protocol ID
- I-NIC 2
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 39908430Capone 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 28939890Capone 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 19189041Grant 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 8074737Capone 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 34480781Varani 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 11976268Capone 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of I-NIC Therapy in Patients With Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT07552818
- Acronym / sponsor ID
- I-NIC 2
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- IGEAIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with the I-NIC medical device for neuroprotection | Active comparator | Device: Treatment with the I-NIC medical device for neuroprotection |
| Treatment with the I-NIC medical device sham | Sham comparator | Device: Treatment with I-NIC sham device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with the I-NIC medical device for neuroprotectionTreatment with low-frequency, low-intensity transcranial magnetic stimulation (ELF-MF) administered using the I-NIC medical device. | Device | Treatment with the I-NIC medical device for neuroprotection |
| Treatment with I-NIC sham deviceThe sham I-NIC device will be connected to a sham solenoid identical to the active solenoid but not emitting any electromagnetic field | Device | Treatment with the I-NIC medical device sham |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 90 days
Percentage of patients achieving an excellent outcome mRS = 0-1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 39908430Psychogios 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.
- Background: PubMed 28939890Capone 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.
- Background: PubMed 19189041Capone 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.
- Background: PubMed 8074737Grant 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.
- Background: PubMed 34480781Capone 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.
- Background: PubMed 11976268Varani 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.
- Background: PubMed 39326864Capone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with the I-NIC medical device for neuroprotection in people with Acute Ischemic Stroke, run by IGEA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona Salati (0039059699600, s.salati@igeamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07552818, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.