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临床试验/NCT06104462
NCT06104462已完成不适用

Exploring the Cortical Hemodynamic Variability of Prefrontal iTBS: a Concurrent TBS/fNIRS Study

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Oxygenated hemoglobin (HbO) change compared to baseline

研究概览

简要总结

An increasing number of studies have used the intermittent theta-burst stimulation (iTBS) protocol to investigate neural plasticity non-invasively in the prefontal cortex in healthy humans and in patients with psychiatric disorders. However, the variability in the neurophysiological response to iTBS stimulation is high. The cause of this variability is multifactorial and to some degree still unknown. Therefore, the current study explores inter- and intra-individual factors that are potentially moderating iTBS-induced excitability changes. A greater understanding of these determinants would be highly valuable for optimizing the therapeutic application of iTBS.

详细描述

The investigators will measure the cortical excitability induced by iTBS with concurrent TBS/fNIRS technique in the same healthy individuals on multiple testing days. Meanwhile, several potential inter- (age, gender, etc.) and intra-individual factors (daily mood, daily physical activity levels, etc.) recently identified in non-invasive transcranial brain stimulation studies will be assessed before applying iTBS to the same individual on each testing day.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthiness based on history and psychiatric assessment
  • being able to hear and understand the verbal instructions
  • completed at least 6 years of formal education

排除标准

  • a current or past diagnosis of psychiatric, neurological disorders, or severe internal illness
  • any conditions that will contraindicate to iTBS or fNIRS
  • psychiatric disorders in their first-degree relatives
  • pregnancy

研究组 & 干预措施

Cortical hemodynamic variability of iTBS and its courses

Experimental

A group of healthy adults shall undergo repeated experimental visits with concurrent TBS/fNIRS (3≤repetition≤15). An interval of at least two days (48 hours) between the visits is required to minimize carry-over effects from the iTBS protocols.

Inter- (age, gender, personality inventory, etc.) and intra-individual factors (daily mood, daily sleep quality, physical activity levels, etc.) that are potentially moderating iTBS-induced excitability changes will be explored.

干预措施: Intermittent theta burst stimulation (iTBS) (Device)

结局指标

主要结局

Oxygenated hemoglobin (HbO) change compared to baseline

时间窗: During and post TBS-fNIRS measurement, up to 3 months

iTBS-induced HbO change in the DLPFC before, during and after stimulation

次要结局

  • Oxygen saturation change compared to baseline(During and post TBS-fNIRS measurement, up to 3 months)
  • Deoxygenated hemoglobin (HbR) change compared to baseline(During and post TBS-fNIRS measurement, up to 3 months)

研究者

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

Dr Georg Kranz

Assistant Professor

The Hong Kong Polytechnic University

研究点 (2)

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