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临床试验/NCT07025759
NCT07025759招募中1 期

Effects of Peripheral Magnetic Stimulation on Cortical Excitability in Healthy Individuals

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

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 excitabilty

研究概览

简要总结

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.

详细描述

This clinical trial is a crossover trial comparing 9 single-session rPMS protocols over the extensor carpi radialis muscle, testing three frequencies (1Hz, 10Hz, 25Hz), intensities (90%, 100%, 110% of resting motor threshold) across sequential phases.

Participants: Healthy adults (18-40 years) undergo pre-/post-intervention assessments: cortical (MEPs, ICI/ICF) excitability.

Design: Crossover, double-blind.

Analysis: ANOVA or Friedman tests (SPSS v20.0; α=0.05).

Significance: Clarifies parameter-specific neuromodulatory effects, guiding future rehabilitation protocols for neurological conditions.

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, both sexes, right-handed (confirmed via Edinburgh Handedness Inventory), and for females, 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 interfering with assessments or interventions; or use of substances altering nervous system excitability.

研究组 & 干预措施

Peripheral magnetic stimulation (110% + 25 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (110% of RMT + 25Hz) (Device)

Peripheral magnetic stimulation (90% + 10 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (90% of RMT + 10 Hz) (Device)

Peripheral magnetic stimulation (90% + 1 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (90% of RMT + 1 Hz) (Device)

Peripheral magnetic stimulation (110% + 10 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (110% of RMT + 10Hz) (Device)

Peripheral magnetic stimulation (100% + 25 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (100% of RMT + 25 Hz) (Device)

Peripheral magnetic stimulation (90% + 25 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (90% of RMT + 25 Hz) (Device)

Peripheral magnetic stimulation (100% + 1 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (100% of RMT + 1 Hz) (Device)

Peripheral magnetic stimulation (100% + 10 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (100% of RMT + 10 Hz) (Device)

Peripheral magnetic stimulation (110% + 1 Hz)

Active Comparator

干预措施: Peripheral magnetic stimulation (110% of RMT + 1Hz) (Device)

结局指标

主要结局

Cortical excitabilty

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

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kátia Monte-Silva

Professor

Universidade Federal de Pernambuco

研究点 (1)

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