Clinical trial NCT01941147: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Acute Stroke
Brain Ischemia
Extremely Low Frequency Magnetic Fields
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Change in National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
measure: Change in Modified Rankin Scale (mRS) score
timeFrame: Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
measure: Change in Barthel Index (BI)
timeFrame: Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
measure: Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI
timeFrame: Baseline; 30 days.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Institute of Neurology, Campus Biomedico University
Study officials:
affiliation: Institute of Neurology, Campus Biomedico University of Rome
name: Vincenzo Di Lazzaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.