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临床试验/NCT07431697
NCT07431697已完成不适用

Boosting and Mapping Non-invasive Brain Stimulation-induced Plasticity in Humans

Ecole Polytechnique Fédérale de Lausanne1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Functional magnetic resonance imaging (fMRI)

研究概览

简要总结

In this study we applied TMS to the hand area of M1 whilst acquiring fMRI of the brain. This study tested whether a higher-frequency form of brain stimulation, called high-gamma (100Hz) intermittent theta burst stimulation (iTBS), more effectively increases brain excitability than the standard 50Hz iTBS. In a double-blind, randomized study with 22 healthy participants, brain activity and motor responses were measured using TMS-fMRI. The 100Hz iTBS condition produced stronger and more consistent increases in motor excitability and greater activation of sensorimotor brain regions compared to 50Hz and sham stimulation, suggesting it may be a more effective approach for non-invasive neuromodulation.

详细描述

This study investigates whether a modified form of brain stimulation called high-gamma intermittent theta burst stimulation (iTBS) can more effectively and consistently increase brain excitability compared to the standard iTBS protocol. iTBS is a non-invasive method that uses magnetic pulses to influence brain activity, but responses vary widely between people.

In this double-blind, randomized, within-subject study, 22 healthy adults completed three sessions of brain stimulation combined with functional MRI (TMS-fMRI). Each participant received conventional 50Hz iTBS, high-gamma 100Hz iTBS, and a sham (placebo) condition on separate visits. Changes in motor cortex excitability were measured using motor-evoked potentials (MEPs), and brain activity and connectivity were assessed using fMRI.

The results showed that 100Hz iTBS produced stronger and more reliable increases in cortical excitability compared to both the 50Hz and sham conditions. High-gamma iTBS also activated broader areas of the sensorimotor network and showed stronger links between stimulation strength and neural response. These findings suggest that high-gamma iTBS may be a more effective and physiologically relevant approach for non-invasive brain stimulation in humans.

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, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Right handed

排除标准

  • Contraindications to either TMS or MRI:
  • Pregnant Metal implants Use of recreational drugs Neurological conditions History of seizures or epilepsy

研究组 & 干预措施

100Hz iTBS (intermittent theta burst protocol of rTMS)

Experimental

The high-frequency of the stimulation is what distinguishes it from the other stimulation types and it is the goal of the study to see if this stimulation protocol is more effective than the classical protocol

干预措施: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) (Device)

50Hz iTBS (intermittent theta burst protocol of rTMS)

Active Comparator

The classical low-frequency protocol of stimulation, this one is being used to compare to the novel high-frequency protocol

干预措施: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) (Device)

Sham iTBS (intermittent theta burst protocol of rTMS)

Sham Comparator

The sham stimulation was delivered with a 50Hz iTBS protocol except that the stimulation intensity was halved so as to retain the sensation of stimulation whilst not activating neurons

干预措施: Intermittent theta burst stimulation (iTBS) as a protocol of repetitive transcranial magnetic stimulation (rTMS) (Device)

结局指标

主要结局

Functional magnetic resonance imaging (fMRI)

时间窗: Throughout the whole experiment, for a total of 26mins

fMRI of the brain and spinal chord were acquired during stimulation with single pulse TMS to elucidate the changes in BOLD activity occurring from the intervention.

Motor evoked potentials (MEPs)

时间窗: MEPs are measured for 8mins immediately before intervention, then 15mins after intervention for a further 8mins.

When single pulses of TMS are applied to M1 hand region, MEPs are evoked in the corresponding hand muscle which can be measured with electromyography (EMG). The amplitude of the MEPs before and after the iTBS interventions are then measured and compared to determine the response to the iTBS, whether this is facilitation, suppression, or no change.

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

Friedhelm Hummel

Full professor

Ecole Polytechnique Fédérale de Lausanne

研究点 (1)

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