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Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

NCT03537469 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-05-29

No results posted yet for this study

Summary

Non-depolarizing magnetic fields, like Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs) have shown the ability to modulate living structures, principally by influencing synaptic activity and ion channels on cellular membranes. Recently, the CTU Mega 20 device was presented as a molecular accelerator, using energy up to 200 Joules and providing high-power (2 Tesla) pulsating fields with a water-repulsive (diamagnetic) action and tissue biostimulation. The investigators tested the hypothesis that LF-PEMFs could modulate long-term corticospinal excitability in healthy brains by applying CTU Mega 20®. Ten healthy subjects without known neurological and/or psychiatric diseases entered the study. A randomized double-blind sham-controlled crossover design was employed, recording TMS parameters (amplitude variation of the motor evoked potential as index of cortical excitability perturbations of the motor system) before (pre) and after (post +0, +15, +30 min) a single CTU Mega 20 session on the corresponding primary right-hand motor area, using a real (magnetic field = 2 Tesla; intensity = 90 J; impulse frequency = 7Hz; duration = 15 minutes) or sham device. A two-way repeated measures ANOVA with TIME (pre, post +0, +15, +30 min) and TREATMENT (real vs sham stimulation) as within-subjects factor was applied.

Conditions

  • Electromagnetic Fields
  • Neuronal Plasticity
  • Transcranial Magnetic Stimulation

Interventions

DEVICE

CTU Mega 20 real device

The CTU Mega 20 diamagnetic acceleration system discharges high-field magnetic impulses (with a duration of 5 ms and a period of 1000 ms), generating a magnetic field up to 2 Tesla, with a frequency of 7500 Hz in a volume of approximately 27 cm3.

DEVICE

CTU Mega 20 sham device

A CTU Mega 20 sham device (with an identical appearance to that of the real device) to avoid treatment identification by the patient or experimenter was used. Of course, the application of this sham device did not provide any magnetic field.

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Mauro Magoni, MD · U.O. Neurologia Vascolare, Azienda Ospedaliera Spedali Civili, Brescia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2016-07-01
Completion
2016-07-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537469 on ClinicalTrials.gov