Effects of Trans-spinal Magnetic Stimulation on Cortical Excitability in Healthy Individuals
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cortical excitability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Trans-spinal magnetic stimulation (10 Hz + 110% MT)
干预措施: Trans-spinal magnetic stimulation (110% MT + 10 Hz) (Device)
Trans-spinal magnetic stimulation (25 Hz + 90% MT)
干预措施: Trans-spinal magnetic stimulation (90% MT + 25 Hz) (Device)
Trans-spinal magnetic stimulation (25 Hz + 100% MT)
干预措施: Trans-spinal magnetic stimulation (100% MT + 25 Hz) (Device)
Trans-spinal magnetic stimulation (25 Hz + 110% MT)
干预措施: Trans-spinal magnetic stimulation (110% MT + 25 Hz) (Device)
Trans-spinal magnetic stimulation (10 Hz + 100% MT)
干预措施: Trans-spinal magnetic stimulation (100% MT + 10 Hz) (Device)
Trans-spinal magnetic stimulation (1 Hz + 90% MT)
干预措施: Trans-spinal magnetic stimulation (90% MT + 1 Hz) (Device)
Trans-spinal magnetic stimulation (1 Hz + 100% MT)
干预措施: Trans-spinal magnetic stimulation (100% MT + 1 Hz) (Device)
Trans-spinal magnetic stimulation (1 Hz + 110% MT)
干预措施: Trans-spinal magnetic stimulation (110% MT + 1 Hz) (Device)
Trans-spinal magnetic stimulation (10 Hz + 90% MT)
干预措施: Trans-spinal magnetic stimulation (90% + 10 Hz) (Device)
结局指标
主要结局
Cortical excitability
时间窗: Baseline (T0), immediately post-stimulation (T1), and at 15 (T2) and 30 minutes (T3) after stimulation.
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
次要结局
未报告次要终点
研究者
Kátia Monte-Silva
Professor
Universidade Federal de Pernambuco