- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767778
Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke (I-NIC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincenzo Di Lazzaro, MD
- Phone Number: +3906225411220
- Email: v.dilazzaro@unicampus.it
Study Contact Backup
- Name: Fioravante Capone, MD
- Phone Number: +3906225411220
- Email: f.capone@unicampus.it
Study Locations
-
-
-
Rome, Italy, 00128
- Institute of Neurology, Campus Biomedico University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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 |
---|---|
Experimental: REAL Pulsed ELF-MF stimulation
Patients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.
|
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 Comparator: SHAM Pulsed ELF-MF stimulation
Patients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and 45 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in NIHSS score
Time Frame: Baseline and 90 days
|
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.
|
Baseline and 90 days
|
Change in mRS score
Time Frame: Baseline and 90 days
|
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
Time Frame: Baseline and 90 days
|
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.
Time Frame: 90 days
|
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.
Time Frame: 5 days
|
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.
Time Frame: 5 days
|
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 .
Time Frame: 7 days
|
7 days
|
|
Incidence of mortality
Time Frame: 90 days
|
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
Time Frame: 90 days
|
90 days
|
|
Incidence of discomfort during treatment sessions
Time Frame: 90 days
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Vincenzo Di Lazzaro, MD, Institute of Neurology, Campus Biomedico University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-NIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Ischemic Stroke
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
University Hospital, BrestCompletedStroke, Ischemic | Stroke HemorrhagicFrance
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Australia, Sweden, Canada, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, China, Greece, Japan, Turkey, Netherlands, Romania, United Kingdom, Portugal, Hungary, Italy, Brazil, France, S... and more
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
Clinical Trials on REAL Pulsed ELF-MF stimulation
-
Campus Bio-Medico UniversityUnknown
-
Autonomous University of MorelosInstituto Mexicano del Seguro Social; Universidad Autonoma de Nuevo LeonCompletedNeuropathic Diabetic Ulcer - FootMexico
-
Hospital Son LlatzerRecruiting
-
IRCCS Centro Neurolesi "Bonino-Pulejo"RecruitingBrain Injuries | Neurologic DisorderItaly
-
TheraBracelet, Inc.Medical University of South CarolinaCompletedStroke | Hemiparesis | Cerebrovascular Accident | Stroke Rehabilitation | Upper Extremity | Hand FunctionUnited States
-
Shanghai General Hospital, Shanghai Jiao Tong University...Recruiting
-
Western University, CanadaNot yet recruitingHuntington Disease
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingStroke | Physical DisabilityUnited States
-
Medical University of South CarolinaMUSC Foundation for Research DevelopmentCompleted
-
Western University, CanadaUnknown