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

Universidade Federal de Pernambuco

Status and phase: Enrolling; Phase 1

Conditions: Healthy Individuals

Treatments: Device: Trans-spinal magnetic stimulation (90% MT + 25 Hz); Device: Trans-spinal magnetic stimulation (110% MT + 25 Hz); Device: Trans-spinal magnetic stimulation (100% MT + 25 Hz); Device: Trans-spinal magnetic stimulation (90% + 10 Hz); Device: Trans-spinal magnetic stimulation (110% MT + 10 Hz); Device: Trans-spinal magnetic stimulation (100% MT + 10 Hz); Device: Trans-spinal magnetic stimulation (100% MT + 1 Hz); Device: Trans-spinal magnetic stimulation (110% MT + 1 Hz); Device: Trans-spinal magnetic stimulation (90% MT + 1 Hz)

Study type: Interventional

Funder types: Other

Identifiers

NCT07026760

58678222.8.0000.5208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 9 patient groups

Trans-spinal magnetic stimulation (1 Hz + 90% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (90% MT + 1 Hz)

Trans-spinal magnetic stimulation (1 Hz + 100% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (100% MT + 1 Hz)

Trans-spinal magnetic stimulation (1 Hz + 110% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (110% MT + 1 Hz)

Trans-spinal magnetic stimulation (10 Hz + 90% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (90% + 10 Hz)

Trans-spinal magnetic stimulation (10 Hz + 100% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (100% MT + 10 Hz)

Trans-spinal magnetic stimulation (10 Hz + 110% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (110% MT + 10 Hz)

Trans-spinal magnetic stimulation (25 Hz + 90% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (90% MT + 25 Hz)

Trans-spinal magnetic stimulation (25 Hz + 100% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (100% MT + 25 Hz)

Trans-spinal magnetic stimulation (25 Hz + 110% MT)

Active Comparator group

Treatment:

Device: Trans-spinal magnetic stimulation (110% MT + 25 Hz)