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临床试验/NCT05623696
NCT05623696招募中不适用

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex (DLPFC) on Hypercapnic Air Hunger Induced in Healthy Individuals.

Oxford Brookes University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
16
试验地点
2
主要终点
Air hunger

研究概览

简要总结

The purpose of this study is to see if the front part of the brain called the "Dorsolateral Prefrontal Cortex" (DLPFC) has a role in our ability to feel breathlessness. The experiment will use a device that sits on the top of the head which produces a magnetic field that penetrates the scalp and excites the brain tissue directly under it. This procedure is called repetitive transcranial magnetic stimulation (rTMS), it is a painless procedure and known to be safe in healthy individuals. Previous research has shown that the pain felt when capsaicin, the active ingredient in 'chilli' powder, is applied to the hand is reduced by applying the rTMS on the scalp directly above the DLPFC part of the brain. In this experiment we want to see if breathlessness is also reduced. We will use a breathing task that will generate a moderate amount of breathlessness by adding a small amount of carbon dioxide to the inhaled air, while preventing the increase in the amount of breathing we would normally see in response to this. If we find that breathlessness produced by this breathing task is reduced after rTMS over the DLPFC, this may lead to new drugs that target this part of the brain in patients suffering from breathlessness due to heart or lung disease. The study will also improve our knowledge of how the brain enables us to feel breathlessness

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

Masking will only be applied to the participants in relation to whether they receive sham or actual rTMS.

入排标准

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

入选标准

  • healthy individuals, over 18 years old, with no history of heart, lung or neurological conditions

排除标准

  • Any history of respiratory problems (including Asthma that involves regular use of inhalers)
  • Any history of heart or circulatory problems (e.g. palpitations, arrhythmias, angina, BP)
  • Any history of epilepsy, convulsions or seizures, migraines, or fainting
  • Any history of anxiety disorders (e.g. panic attacks)
  • Any history of serious head injury or brain surgery
  • Any metal parts in the head (except dental wire)
  • Any implants (e.g. pacemaker, insulin pump, neurostimulator)
  • Pregnancy or problems with alcohol or drug abuse.

结局指标

主要结局

Air hunger

时间窗: Average of 4 steady state ratings in the last minute of air hunger tests

Visual analog scale ratings of air hunger

次要结局

  • Dyspnoea-12 total, physical and emotion scores(Administered immediately following pre and post intervention air hunger tests in relation to the "test just completed")
  • Mood assessment(immediately following pre and post intervention air hunger tests)
  • Trait and state anxiety scores(immediately following pre and post intervention air hunger tests)

研究者

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

Dr. Shakeeb H Moosavi

Reader in Clinical Physiology

Oxford Brookes University

研究点 (2)

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