Effects of Trans-spinal Magnetic Stimulation on Cortical Excitability in Healthy Individuals
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2022
Typical duration for phase_1
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedJune 18, 2025
June 1, 2025
3 years
June 10, 2025
June 10, 2025
Conditions
Keywords
Outcome Measures
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
Baseline (T0), immediately post-stimulation (T1), and at 15 (T2) and 30 minutes (T3) after stimulation.
Study Arms (9)
Trans-spinal magnetic stimulation (1 Hz + 90% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (1 Hz + 100% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (1 Hz + 110% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (10 Hz + 90% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (10 Hz + 100% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (10 Hz + 110% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (25 Hz + 90% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (25 Hz + 100% MT)
ACTIVE COMPARATORTrans-spinal magnetic stimulation (25 Hz + 110% MT)
ACTIVE COMPARATORInterventions
Low frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
Low frequency stimulation (1 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
Low frequency stimulation (1 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
High frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
High frequency stimulation (10 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
High frequency stimulation (10 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
High frequency stimulation (25 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
High frequency stimulation (25 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
High frequency stimulation (25 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740-560, Brazil
Central Study Contacts
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 10, 2025
First Posted
June 18, 2025
Study Start
October 1, 2022
Primary Completion
September 30, 2025
Study Completion
October 30, 2025
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share