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Recruiting NCT07026760

Effects of Trans-spinal 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: Trans-spinal magnetic stimulation (90% MT + 1 Hz), Trans-spinal magnetic stimulation (100% MT + 1 Hz), Trans-spinal magnetic stimulation (110% MT + 1 Hz), Trans-spinal magnetic stimulation (90% + 10 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 and intensity) of trans-spinal magnetic stimulation (TsMS) 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 (MEP), intracortical inhibition (ICI), and facilitation (ICF). Findings may enhance non-invasive therapeutic strategies for neurological disorders.

Detailed description

This clinical trial comprises one arm: it evaluates trans-spinal magnetic stimulation (TsMS) applied at the C7 vertebral level, testing three frequencies (1 Hz, 10 Hz, and 25 Hz) and three intensities (90%, 100%, and 110% of the resting motor threshold) across sequential phases.

Methods: The study is a crossover, double-blind trial in which healthy adults (aged 18-40 years) undergo pre- and post-intervention assessments of cortical excitability (MEP, ICI, and ICF). Statistical analyses will be performed using ANOVA or Friedman tests (SPSS v.26).

The results will clarify whether the neuromodulatory effects of the stimulation are parameter-dependent and will guide future rehabilitation protocols for neurological conditions.

The research was approved by the Ethics Committee of the Federal University of Pernambuco (Resolution 466/12). All data will be stored securely for the next five years.

Interventions

  • Device Trans-spinal magnetic stimulation (90% MT + 1 Hz)
    Low frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (100% MT + 1 Hz)
    Low frequency stimulation (1 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (110% MT + 1 Hz)
    Low frequency stimulation (1 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (90% + 10 Hz)
    High frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (100% MT + 10 Hz)
    High frequency stimulation (10 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (110% MT + 10 Hz)
    High frequency stimulation (10 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (90% MT + 25 Hz)
    High frequency stimulation (25 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (100% MT + 25 Hz)
    High frequency stimulation (25 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
  • Device Trans-spinal magnetic stimulation (110% MT + 25 Hz)
    High frequency stimulation (25 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.

Primary outcome measures

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

Eligibility criteria

Healthy adults aged 18-40 years, of both sexes; right-handed (confirmed via the Edinburgh Handedness Inventory); and for women, 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 that could interfere with assessments or interventions; or use of substances that alter 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: NCT07026760 · 58678222.8.0000.5208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗