Stroke, AcuteI-NICNCT02767778
Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke
A study testing REAL Pulsed ELF-MF stimulation in people with Stroke, Acute and Ischemic Stroke, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke, Acute, Ischemic Stroke
- What is being tested?
- REAL Pulsed ELF-MF stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first onset, mono-hemispheric ischemic stroke in the middle cerebral artery territory;
- onset of symptoms within 48 hours;
- National Institutes of Health Stroke Scale (NIHSS) score between 4 and 25;
- signed written informed consent.
Who cannot join
- acute intracranial hemorrhage;
- previous ischemic or hemorrhagic stroke;
- lacunar stroke, defined as not involving the cortex and < 2.0 cm if measured on MRI diffusion-weighted images;
- contraindications to transcranial magnetic stimulation such as implanted metallic parts of implanted electronic devices or other metal in body;
- historical modified Rankin Scale (mRS) >1;
- other serious or complex disease that may confound treatment assessment;
- women known to be pregnant, lactating or having a positive or indeterminate pregnancy test;
- current participation in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effectiveness of Low-frequency Pulsed Electromagnetic Fields (ELF-MF) in Acute Ischemic Stroke
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.
- Conditions
- Stroke, Acute, Ischemic Stroke
- Being tested
- REAL Pulsed ELF-MF stimulation, SHAM Pulsed ELF-MF stimulation
- Keywords
- Acute ischemic stroke, Neuroprotection, Extremely low frequency magnetic fields
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAL Pulsed ELF-MF stimulationDevice
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.
SHAM Pulsed ELF-MF stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: REAL Pulsed ELF-MF stimulation |
| 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. Receives: Device: SHAM Pulsed ELF-MF stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 45 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 5 days
Number of participants with hemorrhagic transformation of ischemic lesion at MRI .
Measured: 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.
Measured: 90 days
Number of patients requiring to stop treatment sessions
Measured: 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.
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 posted10 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2023
- Study completionAug 2023
Why it stopped: Interim analysis showed positive results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Collaborators
- Nuovo Ospedale Civile S.Agostino Estense, San Raffaele University Hospital, Italy, University Hospital of Ferrara, Azienda USL Reggio Emilia - IRCCS, University of Rome Tor Vergata, Ospedale Sant'Eugenio di Roma, Italy
- Responsible party
- Principal investigator, Di Lazzaro Vincenzo, Campus Bio-Medico University
- Investigators
- Vincenzo Di Lazzaro, MD, Study director, Institute of Neurology, Campus Biomedico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767778
- Sponsor's protocol ID
- I-NIC
- Acronym
- I-NIC
- Status last verified
- Oct 2023
- First submitted
- 27 Apr 2016
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effectiveness of Low-frequency Pulsed Electromagnetic Fields (ELF-MF) in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02767778
- Acronym / sponsor ID
- I-NIC / I-NIC
- Conditions
- Stroke, Acute, Ischemic Stroke
- Keywords
- Acute ischemic stroke, Neuroprotection, Extremely low frequency magnetic fields
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed positive results
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Collaborators
- Nuovo Ospedale Civile S.Agostino Estense, San Raffaele University Hospital, Italy, University Hospital of Ferrara, Azienda USL Reggio Emilia - IRCCS, University of Rome Tor Vergata, Ospedale Sant'Eugenio di Roma, Italy
- Study start
- Apr 2016
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 10 May 2016 (estimated)
- 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 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.
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 |
|---|---|---|
| REAL Pulsed ELF-MF stimulation | Experimental | Device: REAL Pulsed ELF-MF stimulationPatients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines. |
| SHAM Pulsed ELF-MF stimulation | Sham comparator | Device: SHAM Pulsed ELF-MF stimulationPatients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first onset, mono-hemispheric ischemic stroke in the middle cerebral artery territory;
- onset of symptoms within 48 hours;
- National Institutes of Health Stroke Scale (NIHSS) score between 4 and 25;
- signed written informed consent.
Key exclusion criteria (8 listed)
- acute intracranial hemorrhage;
- previous ischemic or hemorrhagic stroke;
- lacunar stroke, defined as not involving the cortex and < 2.0 cm if measured on MRI diffusion-weighted images;
- contraindications to transcranial magnetic stimulation such as implanted metallic parts of implanted electronic devices or other metal in body;
- historical modified Rankin Scale (mRS) >1;
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 |
|---|---|---|
| REAL Pulsed ELF-MF stimulationWithin 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. | Device | REAL Pulsed ELF-MF stimulation |
| SHAM Pulsed ELF-MF stimulationSHAM 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. | Device | SHAM Pulsed ELF-MF stimulation |
Primary outcome
Change in the volume of the ischemic lesion measured by MRI
Time frame: Baseline and 45 days
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).
10 secondary outcomes
Change in NIHSS score
Time frame: Baseline and 90 days
Change in mRS score
Time frame: Baseline and 90 days
Change in Barthel Index score
Time frame: Baseline and 90 days
Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.
Time frame: 90 days
Number of participants with abnormal vital parameters.
Time frame: 5 days
Change in NIHSS score during the 5-days ELF-MF exposure period.
Time frame: 5 days
Number of participants with hemorrhagic transformation of ischemic lesion at MRI .
Time frame: 7 days
Incidence of mortality
Time frame: 90 days
Number of patients requiring to stop treatment sessions
Time frame: 90 days
Incidence of discomfort during treatment sessions
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Interim analysis showed positive results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Vincenzo Di Lazzaro, MD study director
Institute of Neurology, Campus Biomedico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAL Pulsed ELF-MF stimulation in people with Stroke, Acute and Ischemic Stroke, run by Campus Bio-Medico University at 1 site in Italy.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Interim analysis showed positive results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the volume of the ischemic lesion measured by MRI (time frame: Baseline and 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2023.