Clinical trial NCT02767778: Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Acute
Ischemic Stroke
Keywords: Acute ischemic stroke
Neuroprotection
Extremely low frequency magnetic fields
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: Nuovo Ospedale Civile S.Agostino Estense
name: San Raffaele University Hospital, Italy
name: University Hospital of Ferrara
name: Azienda USL Reggio Emilia - IRCCS
name: University of Rome Tor Vergata
name: Ospedale Sant'Eugenio di Roma, Italy
First posted: 2016-05-10
Enrollment: 124
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the volume of the ischemic lesion measured by MRI
timeFrame: Baseline and 45 days
Secondary outcomes:
measure: Change in NIHSS score
timeFrame: Baseline and 90 days
measure: Change in mRS score
timeFrame: Baseline and 90 days
measure: Change in Barthel Index score
timeFrame: Baseline and 90 days
measure: Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.
timeFrame: 90 days
measure: Number of participants with abnormal vital parameters.
timeFrame: 5 days
measure: Change in NIHSS score during the 5-days ELF-MF exposure period.
timeFrame: 5 days
measure: Number of participants with hemorrhagic transformation of ischemic lesion at MRI .
timeFrame: 7 days
measure: Incidence of mortality
timeFrame: 90 days
measure: Number of patients requiring to stop treatment sessions
timeFrame: 90 days
measure: Incidence of discomfort during treatment sessions
timeFrame: 90 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Institute of Neurology, Campus Biomedico University
Study officials:
affiliation: Institute of Neurology, Campus Biomedico University
name: Vincenzo Di Lazzaro, MD
role: STUDY_DIRECTOR
References: