Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

NCT ID: NCT01941147

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31

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.

Conditions

Stroke

Keywords

Acute Stroke; Brain Ischemia; Extremely Low Frequency Magnetic Fields

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed ELF-MF

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).

Group Type: EXPERIMENTAL

pulsed ELF-MF

Intervention Type: DEVICE

(75 Hz, 1,8 mT)

Interventions

pulsed ELF-MF

(75 Hz, 1,8 mT)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Di Lazzaro Vincenzo

Professor - Chair of Neurology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Di Lazzaro, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Neurology, Campus Biomedico University of Rome

Locations

Institute of Neurology, Campus Biomedico University

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo Di Lazzaro, MD

Role: CONTACT

Phone: +39 06 22541 1320

Email: v.dilazzaro@unicampus.it

Facility Contacts

Vincenzo Di Lazzaro, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 23428499 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19189041 (View on PubMed)

Other Identifiers

ELF-01

Identifier Type: -

Identifier Source: org_study_id