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Recruiting NCT07025759

Effects of Peripheral Magnetic Stimulation on Cortical Excitability in Healthy Individuals

Phase I Interventional Healthy Individuals

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral magnetic stimulation (90% of RMT + 1 Hz), Peripheral magnetic stimulation (90% of RMT + 10 Hz), Peripheral magnetic stimulation (90% of RMT + 25 Hz), Peripheral magnetic stimulation (100% of RMT + 1 Hz).
Who it may be relevant to
Registry conditions: Healthy Individuals. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Device Peripheral magnetic stimulation (90% of RMT + 1 Hz)
    Low-frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Peripheral magnetic stimulation (90% of RMT + 10 Hz)
    High-frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, totaling 2400 pulses.
  • Device Peripheral magnetic stimulation (90% of RMT + 25 Hz)
    High-frequency stimulation (25 Hz) at 90% of resting muscle threshold intensity, with 2400 pulses.
  • Device Peripheral magnetic stimulation (100% of RMT + 1 Hz)
    Low-frequency (1 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.
  • Device Peripheral magnetic stimulation (100% of RMT + 10 Hz)
    High-frequency (10 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.
  • Device Peripheral magnetic stimulation (100% of RMT + 25 Hz)
    High-frequency (25 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.
  • Device Peripheral magnetic stimulation (110% of RMT + 1Hz)
    Low-frequency (1 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.
  • Device Peripheral magnetic stimulation (110% of RMT + 10Hz)
    High-frequency (10 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.
  • Device Peripheral magnetic stimulation (110% of RMT + 25Hz)
    High-frequency (25 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Brazil · 1 center
  • Universidade Federal de Pernambuco — Recife

Identifiers

NCT: NCT07025759 · Parameters_pMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗