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Interim analysis showed positive results
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| Name | Class |
|---|---|
| Nuovo Ospedale Civile S.Agostino Estense | OTHER |
| San Raffaele University Hospital, Italy | OTHER |
| University Hospital of Ferrara | OTHER |
| Azienda USL Reggio Emilia - IRCCS |
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The main purpose of this multicentric, prospective, randomized, placebo-controlled, double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients.
124 patients with acute ischemic stroke will be recruited and randomly assigned to real or sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.
The primary outcome will consist of reduction of the expected infarct growth at MR measured in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness, safety and tolerability of pulsed ELF-MF in acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REAL Pulsed ELF-MF stimulation | Experimental | Patients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines. |
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| SHAM Pulsed ELF-MF stimulation | Sham Comparator | Patients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REAL Pulsed ELF-MF stimulation | Device | Within 48 hours from the onset of the stroke, the enrolled patients will undergo to 120 min, daily, pulsed ELF-MF treatment for 5 consecutive days, during their hospital stay.Pulsed ELF-MF stimulation will be administrated by a rectangular, flexible coil, positioned upon the ischemic hemisphere and connected to the pulse generator (B-01; IGEA, Carpi, Italy) producing a single-pulsed signal at 75±2 Hz, with a pulse duration of 1.3 ms and a peak intensity of the magnetic field of 1.8±0.2 mT. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the volume of the ischemic lesion measured by MRI | The effect of pulsed ELF-MF on ischemic lesion volume will be evaluated by MR at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7 and 45 days from the onset of the stroke). | Baseline and 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIHSS score | Clinical evaluations will be performed by means of international well-validated scales (NIHSS) at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7, 45 and 90 days from the onset of the stroke). Clinical outcome measure is the change from baseline in NIHSS score measured at different follow-up after pulsed ELF-MF exposure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Di Lazzaro, MD | Institute of Neurology, Campus Biomedico University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Neurology, Campus Biomedico University | Rome | 00128 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER_GOV |
| University of Rome Tor Vergata | OTHER |
| Ospedale Sant'Eugenio di Roma, Italy | UNKNOWN |
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| SHAM Pulsed ELF-MF stimulation | Device | SHAM pulsed ELF-MF stimulation will be administrated by a rectangular, flexible coil, positioned upon the ischemic hemisphere and connected to the pulse generator (B-01; IGEA, Carpi, Italy). The device for SHAM stimulation is identical and produces the same auditory sensation of the device for REAL stimulation but the SHAM device has no stimulating effect on the brain. |
|
| Baseline and 90 days |
| Change in mRS score | Clinical evaluations will be performed by means of international well-validated scales (mRS) at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7, 45 and 90 days from the onset of the stroke). Clinical outcome measure is the change from baseline in mRS score measured at different follow-up after pulsed ELF-MF exposure. | Baseline and 90 days |
| Change in Barthel Index score | Clinical evaluations will be performed by means of international well-validated scales (Barthel Index) at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7, 45 and 90 days from the onset of the stroke). Clinical outcome measure is the change from baseline in Barthel Index scores measured at different follow-up after pulsed ELF-MF exposure. | Baseline and 90 days |
| Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment. | Safety will be assessed by measuring the incidence of AEs and SAEs throughout the stimulation period and along 3-months follow-up. | 90 days |
| Number of participants with abnormal vital parameters. | During the pulsed ELF-MF stimulation, patients will be continuously monitored by multimodal monitor that simultaneously measures and displays the relevant vital parameters (respiratory rate, heart rate, blood pressure, pulse oximetry). | 5 days |
| Change in NIHSS score during the 5-days ELF-MF exposure period. | Early neurological worsening will be evaluated by change in NIHSS score during the 5-days ELF-MF exposure period. | 5 days |
| Number of participants with hemorrhagic transformation of ischemic lesion at MRI . | 7 days |
| Incidence of mortality | Safety will be assessed by measuring the incidence of mortality throughout the stimulation period and along 3-months follow-up. | 90 days |
| Number of patients requiring to stop treatment sessions | 90 days |
| Incidence of discomfort during treatment sessions | Ad hoc questionnaire to detect any discomfort created by ELF-MF stimulation (e.g. nausea, headache, palpitations, anxiety, sweating) will be administered daily during the whole hospital stay and, after the discharge, at each outward control. | 90 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |