Pilot study to evaluate the safety of low frequency and low intensity transcranial magnetic stimulation (ELF-MF) in patients with acute cerebral ischemia
Project Objectives
The aim of this study is to evaluate the safety of pulsed ELF-MF for the treatment of patients with acute ischemic stroke. This effect could be related to the ability of ELF-MF (already demonstrated in vitro) to modulate the main biochemical mechanisms of ischemic injury and brain plasticity.
The primary objectives of the study are the evaluation of the safety profile of the treatment by monitoring vital signs and adverse events frequency.
The secondary objectives are:
- Assessment of the progression of the size of ischemic area by brain MRI (the first performed before treatment and within 30 days of symptom onset and the second after treatment)
- Assessment of short-term (one week) and long-term (3 months to 12 months) prognosis in treated patients
- Assessment of functional recovery at 3 months and 12 months in treated patients
- Comparison in terms of safety and progression of the ischemic lesion and scores by clinical scales between different patient subgroups, divided according to the duration of daily therapy
Start/End Dates
2013 - 2014
Principal Investigator
Prof. Vincenzo Di Lazzaro
Host institution
- Campus Bio-Medico University of Rome - Neurology Research Unit
- Campus Bio-Medico University of Rome - Physiatrist Research Unit
Source of fundsing
Non-profit project