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

NCT ID: NCT07026760

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Low frequency stimulation (1 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Low frequency stimulation (1 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

High frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

High frequency stimulation (10 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

High frequency stimulation (10 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

High frequency stimulation (25 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

High frequency stimulation (25 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

High frequency stimulation (25 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Kátia Monte-Silva

Role: CONTACT

+55 81 21267579

Facility Contacts

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João Fabrício

Role: primary

+55 81 986450112

Other Identifiers

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58678222.8.0000.5208

Identifier Type: -

Identifier Source: org_study_id

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