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NCT Number: NCT07025759

Effects of Peripheral Magnetic Stimulation on Cortical Excitability in Healthy Individuals

This study investigates the immediate effects of different parameters (frequency, intensity, and pulse number) of peripheral magnetic stimulation (rPMS) on cortical excitability in healthy individuals. Using a randomized, double-blind crossover design, the research aims to identify optimal stimulation protocols for modulating neural activity. Outcomes include measurements of motor-evoked potentials (MEPs), intracortical inhibition (ICI), and facilitation (ICF). Findings may enhance non-invasive therapeutic strategies for neurological disorders.

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Key information

Conditions

Healthy Individuals

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

This clinical trial is a crossover trial comparing 9 single-session rPMS protocols over the extensor carpi radialis muscle, testing three frequencies (1Hz, 10Hz, 25Hz), intensities (90%, 100%, 110% of resting motor threshold) across sequential phases.

Participants: Healthy adults (18-40 years) undergo pre-/post-intervention assessments: cortical (MEPs, ICI/ICF) excitability.

Design: Crossover, double-blind.

Analysis: ANOVA or Friedman tests (SPSS v20.0; α=0.05).

Significance: Clarifies parameter-specific neuromodulatory effects, guiding future rehabilitation protocols for neurological conditions.

Ethics: Approved by Federal University of Pernambuco's ethics committee (Resolution 466/12). Data stored securely for 5 years.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adults aged 18-40 years, both sexes, right-handed (confirmed via Edinburgh Handedness Inventory), and for females, consistent use of contraceptive medication to mitigate hormonal influences on nervous system excitability.

Exclusion criteria

Pregnancy; history of seizures or epilepsy; metallic implants in the head, spine, face, or heart; diagnosed neurological or musculoskeletal conditions interfering with assessments or interventions; or use of substances altering nervous system excitability.

Treatment and study plan

Peripheral magnetic stimulation (90% of RMT + 1 Hz)

Device

Low-frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.

Peripheral magnetic stimulation (90% of RMT + 10 Hz)

Device

High-frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, totaling 2400 pulses.

Peripheral magnetic stimulation (90% of RMT + 25 Hz)

Device

High-frequency stimulation (25 Hz) at 90% of resting muscle threshold intensity, with 2400 pulses.

Peripheral magnetic stimulation (100% of RMT + 1 Hz)

Device

Low-frequency (1 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (100% of RMT + 10 Hz)

Device

High-frequency (10 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (100% of RMT + 25 Hz)

Device

High-frequency (25 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% of RMT + 1Hz)

Device

Low-frequency (1 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% of RMT + 10Hz)

Device

High-frequency (10 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% of RMT + 25Hz)

Device

High-frequency (25 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Primary outcomes

  1. Cortical excitabilty

    Time frame: Baseline (T0), immediately post-stimulation (T1), 15 minutes (T2), and 30 minutes (T3) post-stimulation.

    Cortical excitability will be assessed through motor-evoked potentials (MEPs) elicited by single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), targeting the first dorsal interosseous (FDI) representation area. The hotspot will be determined as the site producing the largest MEP amplitude at the lowest intensity, with stimulation delivered at 100% of the resting motor threshold (RMT). Additionally, paired-pulse TMS protocols will evaluate intracortical inhibition (ICI) and facilitation (ICF) using conditioning stimuli at 80% RMT (3 ms interstimulus interval for ICI, 10 ms for ICF) and test stimuli at 120% RMT. MEP amplitudes will be recorded via surface electromyography (EMG) from the FDI muscle using bipolar electrode placement, with signals sampled at 20,000 Hz (bandpass 5-10,000 Hz) to capture corticospinal excitability changes across timepoints (baseline, post-intervention, and follow-ups).

Study contacts

Contact information is provided by the study sponsor or research team.

Kátia Monte-Silva

CONTACT

[email protected]

+55 81 21267579

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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