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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
(75 Hz, 1,8 mT)
Institute of Neurology, Campus Biomedico University
Rome, Italy
RECRUITINGIncidence 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.
Time frame: 1 year
Change in National Institutes of Health Stroke Scale (NIHSS) score
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
Change in Modified Rankin Scale (mRS) score
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
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
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
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.