Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Pulsed ELF-MF Device
    Intervention Desc: (75 Hz, 1,8 mT)
    ARM 1: Kind: Experimental
    Label: Pulsed ELF-MF
    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).

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of adverse events 1 year Yes
Secondary Change in National Institutes of Health Stroke Scale (NIHSS) score Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment No
Secondary Change in Modified Rankin Scale (mRS) score Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment No
Secondary Change in Barthel Index (BI) Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment No
Secondary Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI Baseline; 30 days. No

Sponsors