search
Back to results

Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke (I-NIC)

Primary Purpose

Stroke, Acute, Ischemic Stroke

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
REAL Pulsed ELF-MF stimulation
SHAM Pulsed ELF-MF stimulation
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Acute ischemic stroke, Neuroprotection, Extremely low frequency magnetic fields

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Neurology, Campus Biomedico University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

REAL Pulsed ELF-MF stimulation

SHAM Pulsed ELF-MF stimulation

Arm Description

Patients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.

Patients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.
Number of participants with hemorrhagic transformation of ischemic lesion at MRI .
Incidence of mortality
Safety will be assessed by measuring the incidence of mortality throughout the stimulation period and along 3-months follow-up.
Number of patients requiring to stop treatment sessions
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.

Full Information

First Posted
April 27, 2016
Last Updated
October 24, 2023
Sponsor
Campus Bio-Medico University
Collaborators
Nuovo Ospedale Civile S.Agostino Estense, San Raffaele University Hospital, Italy, University Hospital of Ferrara, Arcispedale Santa Maria Nuova-IRCCS, University of Rome Tor Vergata, Ospedale Sant'Eugenio di Roma, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT02767778
Brief Title
Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke
Acronym
I-NIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed positive results
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2023 (Actual)
Study Completion Date
August 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
Collaborators
Nuovo Ospedale Civile S.Agostino Estense, San Raffaele University Hospital, Italy, University Hospital of Ferrara, Arcispedale Santa Maria Nuova-IRCCS, University of Rome Tor Vergata, Ospedale Sant'Eugenio di Roma, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Ischemic Stroke
Keywords
Acute ischemic stroke, Neuroprotection, Extremely low frequency magnetic fields

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REAL Pulsed ELF-MF stimulation
Arm Type
Experimental
Arm Description
Patients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.
Arm Title
SHAM Pulsed ELF-MF stimulation
Arm Type
Sham Comparator
Arm Description
Patients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.
Intervention Type
Device
Intervention Name(s)
REAL Pulsed ELF-MF stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SHAM Pulsed ELF-MF stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the volume of the ischemic lesion measured by MRI
Description
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).
Time Frame
Baseline and 45 days
Secondary Outcome Measure Information:
Title
Change in NIHSS score
Description
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.
Time Frame
Baseline and 90 days
Title
Change in mRS score
Description
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.
Time Frame
Baseline and 90 days
Title
Change in Barthel Index score
Description
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.
Time Frame
Baseline and 90 days
Title
Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.
Description
Safety will be assessed by measuring the incidence of AEs and SAEs throughout the stimulation period and along 3-months follow-up.
Time Frame
90 days
Title
Number of participants with abnormal vital parameters.
Description
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).
Time Frame
5 days
Title
Change in NIHSS score during the 5-days ELF-MF exposure period.
Description
Early neurological worsening will be evaluated by change in NIHSS score during the 5-days ELF-MF exposure period.
Time Frame
5 days
Title
Number of participants with hemorrhagic transformation of ischemic lesion at MRI .
Time Frame
7 days
Title
Incidence of mortality
Description
Safety will be assessed by measuring the incidence of mortality throughout the stimulation period and along 3-months follow-up.
Time Frame
90 days
Title
Number of patients requiring to stop treatment sessions
Time Frame
90 days
Title
Incidence of discomfort during treatment sessions
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Di Lazzaro, MD
Organizational Affiliation
Institute of Neurology, Campus Biomedico University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Neurology, Campus Biomedico University
City
Rome
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke

We'll reach out to this number within 24 hrs