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临床试验/NCT05427552
NCT05427552已完成不适用

Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年6月1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
24
试验地点
1
主要终点
Oxygenated hemoglobin (HbO) change compared to baseline

研究概览

简要总结

Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Recent studies show that the relationship between stimulation intensity and prefrontal hemodynamic response is not linear but in an inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup allows the investigators to observe the prefrontal hemodynamic response during stimulation.

The aim of this study is to investigate the effects of different intensities on brain activity during and after the stimulation using fNIRS.

详细描述

Please refer to the full proposal

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
Single (Participant)

盲法说明

Participants will not be informed of the stimulation intensities.

入排标准

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

入选标准

  • •Right-handed

排除标准

  • •history of epilepsy, seizures, or convulsions
  • •current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
  • •current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
  • •with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker

研究组 & 干预措施

Prefrontal hemodynamic response to 50% rMT iTBS

Experimental

Participants will receive 50% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS.

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

Prefrontal hemodynamic response to 70% rMT iTBS

Experimental

Participants will receive 70% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS.

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

Prefrontal hemodynamic response to 90% rMT iTBS

Experimental

Participants will receive 90% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS.

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

Principal Investigator

The Hong Kong Polytechnic University

研究点 (1)

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