StrokeNCT01941147
Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke
A study testing pulsed ELF-MF in people with Stroke, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- pulsed ELF-MF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2013to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Neurology, Campus Biomedico University
Rome, 00128
Vincenzo Di Lazzaro, MD, +39 06 22541 1320, v.dilazzaro@unicampus.it
Fioravante Capone, MD
About this study
Official title: An Open Label, One Arm, Dose Escalation Study to Evaluate the Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke.
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.
- Conditions
- Stroke
- Being tested
- pulsed ELF-MF
- Keywords
- Acute Stroke, Brain Ischemia, Extremely Low Frequency Magnetic Fields
- Medical subject headings
- Stroke, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed ELF-MFDevice
(75 Hz, 1,8 mT)
| Study group | Role | What they receive |
|---|---|---|
| Pulsed ELF-MF | Experimental | 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). Receives: Device: pulsed ELF-MF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Change in National Institutes of Health Stroke Scale (NIHSS) score
NIHSS is a validated scale from 1-42 to evaluate stroke severity
Measured: Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change in Modified Rankin Scale (mRS) score
mRS is a straightforward evaluation of the functional limitations from stroke
Measured: Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
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
Measured: Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
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.
Measured: Baseline; 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Lazzaro Vincenzo, Campus Bio-Medico University
- Investigators
- Vincenzo Di Lazzaro, MD, Principal investigator, Institute of Neurology, Campus Biomedico University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941147
- Sponsor's protocol ID
- ELF-01
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23428499Capone 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.
PubMed 19189041
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, One Arm, Dose Escalation Study to Evaluate the Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT01941147
- Acronym / sponsor ID
- ELF-01
- Conditions
- Stroke
- Keywords
- Acute Stroke, Brain Ischemia, Extremely Low Frequency Magnetic Fields
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 13 Sep 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed ELF-MF | Experimental | Device: pulsed ELF-MFNine 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| pulsed ELF-MF(75 Hz, 1,8 mT) | Device | Pulsed ELF-MF |
Primary outcome
Incidence of adverse events
Time frame: 1 year
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.
4 secondary outcomes
Change in National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change in Modified Rankin Scale (mRS) score
Time frame: Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change in Barthel Index (BI)
Time frame: Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI
Time frame: Baseline; 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Background: PubMed 23428499Di 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.
- Background: PubMed 19189041Capone 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.
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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 principal investigator
Institute of Neurology, Campus Biomedico University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed ELF-MF in people with 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Sep 2013. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Di Lazzaro, MD (+39 06 22541 1320, v.dilazzaro@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941147, which also lists 2 linked publications.
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 13 Sep 2013.