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

ConditionHealthy Individuals
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversidade Federal de Pernambuco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Device

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

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

    Device

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

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

    Device

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

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

    Device

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

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

    Device

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

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

    Device

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

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

    Device

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

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

    Device

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

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

    Device

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

Treatment groups

18 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Trans-spinal magnetic stimulation (1 Hz + 90% MT)Active comparator 1 intervention
Group B: Trans-spinal magnetic stimulation (1 Hz + 100% MT)Active comparator 1 intervention
Group C: Trans-spinal magnetic stimulation (1 Hz + 110% MT)Active comparator 1 intervention
Group D: Trans-spinal magnetic stimulation (10 Hz + 90% MT)Active comparator 1 intervention
Group E: Trans-spinal magnetic stimulation (10 Hz + 100% MT)Active comparator 1 intervention
Group F: Trans-spinal magnetic stimulation (10 Hz + 110% MT)Active comparator 1 intervention
Group G: Trans-spinal magnetic stimulation (25 Hz + 90% MT)Active comparator 1 intervention
Group H: Trans-spinal magnetic stimulation (25 Hz + 100% MT)Active comparator 1 intervention
Group I: Trans-spinal magnetic stimulation (25 Hz + 110% MT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cortical excitability

Cortical excitability will be assessed using motor-evoked potentials (MEPs) elicited by single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), specifically targeting the cortical representation of the first dorsal interosseous (FDI) muscle. The stimulation hotspot will be defined as the scalp location that elicits the largest and most consistent MEP amplitude at the lowest stimulation intensity. Single-pulse TMS will be delivered at 100% of the resting motor threshold (RMT). Paired-pulse TMS protocols will be used to evaluate intracortical inhibition (ICI) and intracortical facilitation (ICF), using a subthreshold conditioning stimulus set at 80% of RMT and a suprathreshold test stimulus set at 120% of RMT, with interstimulus intervals of 3 ms for ICI and 10 ms for ICF. MEP amplitudes will be recorded from the FDI muscle using bipolar surface electromyography (EMG). Signals will be digitized at 20,000 Hz (bandpass 5-10,000 Hz) for offlin

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal de Pernambuco

Lead sponsor

Source ClinicalTrials.gov
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