Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03537469
• Collaborator: (none)
• Enrollment: 10
• Arms: 2
• Actual Duration (Months): 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Electromagnetic Fields; Neuronal Plasticity; Transcranial Magnetic Stimulation	Device: CTU Mega 20 real device; Device: CTU Mega 20 sham device	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Basic Science
• Official Title: Modulation of Long-Term Potentiation-Like Cortical Plasticity in the Healthy Brain With Low Frequency-Pulsed Electromagnetic Fields
• Actual Study Start Date: Mar 10, 2016
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 10, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cortical Excitability change across time [Baseline and after 15, and 30 minutes]

   Motor evoked potential (MEP) amplitude registered by TMS after sham or real stimulation at different time points, evaluating the differences among timepoints.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects between 18 and 35 years

Exclusion Criteria:

• Known neurological or psychiatric diseases

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

• Principal Investigator: Mauro Magoni, MD, U.O. Neurologia Vascolare, Azienda Ospedaliera Spedali Civili, Brescia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MAURO MAGONI, Head of U.O. Neurologia Vascolare, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• ClinicalTrials.gov Identifier: NCT03537469
• Other Study ID Numbers: NP-2322
• First Posted: May 25, 2018
• Last Update Posted: May 29, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 29, 2018