Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

NCT03537469 | Completed Early Phase 1 DMC

• 1 other identifier: NP-2322
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CTU Mega 20 real device

EXPERIMENTAL

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

CTU Mega 20 sham device

SHAM COMPARATOR

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

Interventions

CTU Mega 20 real device 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.

CTU Mega 20 real device

CTU Mega 20 sham device 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.

CTU Mega 20 sham device

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects between 18 and 35 years

You may not qualify if:

• Known neurological or psychiatric diseases

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Related Publications (1)

• 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.

  PMID: 29895259 DERIVED

Study Officials

• Mauro Magoni, MD

  U.O. Neurologia Vascolare, Azienda Ospedaliera Spedali Civili, Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects and operators who performed TMS were blinded to the type of stimulation applied, we then employed a randomized double-blind sham-controlled crossover design.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of U.O. Neurologia Vascolare

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 25, 2018
• Study Start: March 10, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 10, 2016
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share