NCT07025759

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

June 9, 2025

Last Update Submit

June 16, 2025

Conditions

Keywords

Peripheral Magnetic StimulationCortical Excitabilty

Outcome Measures

Primary Outcomes (1)

  • Cortical excitabilty

    Cortical excitability will be assessed through motor-evoked potentials (MEPs) elicited by single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), targeting the first dorsal interosseous (FDI) representation area. The hotspot will be determined as the site producing the largest MEP amplitude at the lowest intensity, with stimulation delivered at 100% of the resting motor threshold (RMT). Additionally, paired-pulse TMS protocols will evaluate intracortical inhibition (ICI) and facilitation (ICF) using conditioning stimuli at 80% RMT (3 ms interstimulus interval for ICI, 10 ms for ICF) and test stimuli at 120% RMT. MEP amplitudes will be recorded via surface electromyography (EMG) from the FDI muscle using bipolar electrode placement, with signals sampled at 20,000 Hz (bandpass 5-10,000 Hz) to capture corticospinal excitability changes across timepoints (baseline, post-intervention, and follow-ups).

    Baseline (T0), immediately post-stimulation (T1), 15 minutes (T2), and 30 minutes (T3) post-stimulation.

Study Arms (9)

Peripheral magnetic stimulation (90% + 1 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (90% of RMT + 1 Hz)

Peripheral magnetic stimulation (100% + 25 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (100% of RMT + 25 Hz)

Peripheral magnetic stimulation (90% + 25 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (90% of RMT + 25 Hz)

Peripheral magnetic stimulation (100% + 1 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (100% of RMT + 1 Hz)

Peripheral magnetic stimulation (100% + 10 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (100% of RMT + 10 Hz)

Peripheral magnetic stimulation (110% + 1 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (110% of RMT + 1Hz)

Peripheral magnetic stimulation (110% + 10 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (110% of RMT + 10Hz)

Peripheral magnetic stimulation (110% + 25 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (110% of RMT + 25Hz)

Peripheral magnetic stimulation (90% + 10 Hz)

ACTIVE COMPARATOR
Device: Peripheral magnetic stimulation (90% of RMT + 10 Hz)

Interventions

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

Peripheral magnetic stimulation (90% + 1 Hz)

High-frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, totaling 2400 pulses.

Peripheral magnetic stimulation (90% + 10 Hz)

High-frequency stimulation (25 Hz) at 90% of resting muscle threshold intensity, with 2400 pulses.

Peripheral magnetic stimulation (90% + 25 Hz)

Low-frequency (1 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (100% + 1 Hz)

High-frequency (10 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (100% + 10 Hz)

High-frequency (25 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (100% + 25 Hz)

Low-frequency (1 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% + 1 Hz)

High-frequency (10 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% + 10 Hz)

High-frequency (25 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% + 25 Hz)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

RECRUITING

Central Study Contacts

Kátia Monte-Silva

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

October 1, 2022

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations