Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

Modulation of Long-Term Potentiation-Like Cortical Plasticity in the Healthy Brain With Low Frequency-Pulsed Electromagnetic Fields

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.

Study Overview

• Status: Completed
• Conditions: Transcranial Magnetic Stimulation; Neuronal Plasticity; Electromagnetic Fields
• Intervention / Treatment: Device: CTU Mega 20 real device; Device: CTU Mega 20 sham device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects between 18 and 35 years

Exclusion Criteria:

• Known neurological or psychiatric diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CTU Mega 20 real device; A single-session of real CTU Mega 20 on the corresponding primary right-hand motor area, using the real (magnetic field = 2 Tesla; intensity = 90 J; frequency of impulses = 7Hz; duration = 15 minutes) CTU Mega 20 device. This real stimulation provided a Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs).	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.
SHAM_COMPARATOR: CTU Mega 20 sham device; A single-session of sham CTU Mega 20 on the corresponding primary right-hand motor area (magnetic field = 0 Tesla; intensity = 0 J; frequency of impulses = 7Hz; duration = 15 minutes). The sham stimulation did not provide a Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical Excitability change across time	Motor evoked potential (MEP) amplitude registered by TMS after sham or real stimulation at different time points, evaluating the differences among timepoints.	Baseline and after 15, and 30 minutes

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Investigators: Principal Investigator: Mauro Magoni, MD, U.O. Neurologia Vascolare, Azienda Ospedaliera Spedali Civili, Brescia

Publications and helpful links

General Publications

• Premi E, Benussi A, La Gatta A, Visconti S, Costa A, Gilberti N, Cantoni V, Padovani A, Borroni B, Magoni M. Modulation of long-term potentiation-like cortical plasticity in the healthy brain with low frequency-pulsed electromagnetic fields. BMC Neurosci. 2018 Jun 13;19(1):34. doi: 10.1186/s12868-018-0434-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 10, 2016

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (ACTUAL): May 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2018
• Last Update Submitted That Met QC Criteria: May 24, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NP-2322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No