Clinical Trials Directory

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RecruitingNCT07026760

Effects of Trans-spinal Magnetic Stimulation on Cortical Excitability in Healthy Individuals

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
Universidade Federal de Pernambuco · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICETrans-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.
DEVICETrans-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.
DEVICETrans-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.
DEVICETrans-spinal magnetic stimulation (90% + 10 Hz)High frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
DEVICETrans-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.
DEVICETrans-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.
DEVICETrans-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.
DEVICETrans-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.
DEVICETrans-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.

Timeline

Start date
2022-10-01
Primary completion
2025-09-30
Completion
2025-10-30
First posted
2025-06-18
Last updated
2025-06-18

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT07026760. Inclusion in this directory is not an endorsement.