A Multicentric, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effectiveness of Low-frequency Pulsed Electromagnetic Fields (ELF-MF) in Acute Ischemic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Change in the volume of the ischemic lesion measured by MRI
Study Overview
Brief Summary
The main purpose of this multicentric, prospective, randomized, placebo-controlled, double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients.
124 patients with acute ischemic stroke will be recruited and randomly assigned to real or sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.
The primary outcome will consist of reduction of the expected infarct growth at MR measured in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness, safety and tolerability of pulsed ELF-MF in acute ischemic stroke.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •first onset, mono-hemispheric ischemic stroke in the middle cerebral artery territory;
- •onset of symptoms within 48 hours;
- •National Institutes of Health Stroke Scale (NIHSS) score between 4 and 25;
- •signed written informed consent.
Exclusion Criteria
- •acute intracranial hemorrhage;
- •previous ischemic or hemorrhagic stroke;
- •lacunar stroke, defined as not involving the cortex and < 2.0 cm if measured on MRI diffusion-weighted images;
- •contraindications to transcranial magnetic stimulation such as implanted metallic parts of implanted electronic devices or other metal in body;
- •historical modified Rankin Scale (mRS) >1;
- •other serious or complex disease that may confound treatment assessment;
- •women known to be pregnant, lactating or having a positive or indeterminate pregnancy test;
- •current participation in another study.
Outcomes
Primary Outcomes
Change in the volume of the ischemic lesion measured by MRI
Time Frame: Baseline and 45 days
The effect of pulsed ELF-MF on ischemic lesion volume will be evaluated by MR at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7 and 45 days from the onset of the stroke).
Secondary Outcomes
- Number of patients requiring to stop treatment sessions(90 days)
- Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.(90 days)
- Change in NIHSS score(Baseline and 90 days)
- Number of participants with hemorrhagic transformation of ischemic lesion at MRI .(7 days)
- Incidence of mortality(90 days)
- Change in Barthel Index score(Baseline and 90 days)
- Change in mRS score(Baseline and 90 days)
- Number of participants with abnormal vital parameters.(5 days)
- Change in NIHSS score during the 5-days ELF-MF exposure period.(5 days)
- Incidence of discomfort during treatment sessions(90 days)
Investigators
Di Lazzaro Vincenzo
Prof
Campus Bio-Medico University