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Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
pulsed ELF-MF
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute Stroke, Brain Ischemia, Extremely Low Frequency Magnetic Fields

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • males or females, aged over 18
  • evidence of mono-hemispheric ischemic stroke confirmed by brain MRI
  • first onset stroke patients
  • onset of symptoms within 48 hours prior to enrollment
  • National Institutes of Health Stroke Scale (NIHSS) score greater than 4
  • patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
  • signed written informed consent prior to entry into the study

Exclusion Criteria:

  • acute intracranial hemorrhage confirmed by brain CT or MRI scan
  • previous ischemic or hemorrhagic stroke
  • seizure at the onset of stroke or a history of epilepsy
  • contraindications to transcranial magnetic stimulation: implanted metallic parts of implanted electronic devices, including pacemakers,defibrillators, implanted medication pump, or implanted brain stimulator
  • aneurysm clip or other metal in body
  • life expectancy less than 3 months
  • other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, or complex disease that may confound treatment assessment
  • women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
  • any condition that would prevent the subject from giving voluntary informed consent
  • current participation in another study with an investigational drug or device

Sites / Locations

  • Institute of Neurology, Campus Biomedico UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulsed ELF-MF

Arm Description

Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF at increasing daily exposure (45, 120, 240 min).

Outcomes

Primary Outcome Measures

Incidence of adverse events
The primary outcome will be evaluated by the incidence of adverse events (AEs), severe AEs (SAEs) and mortality throughout the stimulation period and the 1-year follow-up.

Secondary Outcome Measures

Change in National Institutes of Health Stroke Scale (NIHSS) score
NIHSS is a validated scale from 1-42 to evaluate stroke severity
Change in Modified Rankin Scale (mRS) score
mRS is a straightforward evaluation of the functional limitations from stroke
Change in Barthel Index (BI)
BI is a reliable disability profile scale from 0 to 15 to evaluate a patient's self-care abilities in 10 areas, including bowel and bladder control
Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI
ΔILV is defined as ILV measured by FLAIR sequence at 30 days after pulsed ELF-MF treatment minus the initial ILV measured by diffusion-weighted imaging (DWI) trace sequence before pulsed ELF-MF treatment.

Full Information

First Posted
September 9, 2013
Last Updated
September 9, 2013
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT01941147
Brief Title
Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke
Official Title
An Open Label, One Arm, Dose Escalation Study to Evaluate the Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is great interest in the development of novel therapies for acute ischemic stroke because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for acute ischemic stroke therapy because of their effects on the main mechanisms of brain ischemic damage and regeneration.The main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective tool to promote recovery in acute ischemic stroke patients Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be evaluated by the incidence of adverse events and mortality throughout the stimulation period and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical and radiological scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute Stroke, Brain Ischemia, Extremely Low Frequency Magnetic Fields

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed ELF-MF
Arm Type
Experimental
Arm Description
Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF at increasing daily exposure (45, 120, 240 min).
Intervention Type
Device
Intervention Name(s)
pulsed ELF-MF
Intervention Description
(75 Hz, 1,8 mT)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
The primary outcome will be evaluated by the incidence of adverse events (AEs), severe AEs (SAEs) and mortality throughout the stimulation period and the 1-year follow-up.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in National Institutes of Health Stroke Scale (NIHSS) score
Description
NIHSS is a validated scale from 1-42 to evaluate stroke severity
Time Frame
Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Title
Change in Modified Rankin Scale (mRS) score
Description
mRS is a straightforward evaluation of the functional limitations from stroke
Time Frame
Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Title
Change in Barthel Index (BI)
Description
BI is a reliable disability profile scale from 0 to 15 to evaluate a patient's self-care abilities in 10 areas, including bowel and bladder control
Time Frame
Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Title
Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI
Description
ΔILV is defined as ILV measured by FLAIR sequence at 30 days after pulsed ELF-MF treatment minus the initial ILV measured by diffusion-weighted imaging (DWI) trace sequence before pulsed ELF-MF treatment.
Time Frame
Baseline; 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: males or females, aged over 18 evidence of mono-hemispheric ischemic stroke confirmed by brain MRI first onset stroke patients onset of symptoms within 48 hours prior to enrollment National Institutes of Health Stroke Scale (NIHSS) score greater than 4 patient is alert, medically stable according to the treating physician and able to follow simple verbal commands signed written informed consent prior to entry into the study Exclusion Criteria: acute intracranial hemorrhage confirmed by brain CT or MRI scan previous ischemic or hemorrhagic stroke seizure at the onset of stroke or a history of epilepsy contraindications to transcranial magnetic stimulation: implanted metallic parts of implanted electronic devices, including pacemakers,defibrillators, implanted medication pump, or implanted brain stimulator aneurysm clip or other metal in body life expectancy less than 3 months other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, or complex disease that may confound treatment assessment women known to be pregnant, lactating or having a positive or indeterminate pregnancy test any condition that would prevent the subject from giving voluntary informed consent current participation in another study with an investigational drug or device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Di Lazzaro, MD
Phone
+39 06 22541 1320
Email
v.dilazzaro@unicampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Di Lazzaro, MD
Organizational Affiliation
Institute of Neurology, Campus Biomedico University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neurology, Campus Biomedico University
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Di Lazzaro, MD
Phone
+39 06 22541 1320
Email
v.dilazzaro@unicampus.it
First Name & Middle Initial & Last Name & Degree
Fioravante Capone, MD
First Name & Middle Initial & Last Name & Degree
Marzia Corbetto, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23428499
Citation
Di Lazzaro V, Capone F, Apollonio F, Borea PA, Cadossi R, Fassina L, Grassi C, Liberti M, Paffi A, Parazzini M, Varani K, Ravazzani P. A consensus panel review of central nervous system effects of the exposure to low-intensity extremely low-frequency magnetic fields. Brain Stimul. 2013 Jul;6(4):469-76. doi: 10.1016/j.brs.2013.01.004. Epub 2013 Feb 4.
Results Reference
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PubMed Identifier
19189041
Citation
Capone 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.
Results Reference
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Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

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