Effect of Non-invasive Magnetic Stimulation of the Brain on Breathlessness in Healthy Individuals.

Study Overview
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Brief Summary
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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

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

Conditions
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Dyspnea

Intervention / Treatment
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* Device: Sham or actual non-invasive (Magnetic) brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy individuals, over 18 years old, with no history of heart, lung or neurological conditions Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Following a practice session, there will be 3 intervention arms presented in random order on 3 separate days. The three arms will be: (i) 10-20mins of 5Hz rTMS over left DLPFC (Arm 1), (ii) 5Hz rTMS over right DLPFC (Arm 2), (iii) sham rTMS (Arm 3). A standard steady state air hunger test will be conducted before and immediately after each intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation of Left DLPFC<br>Intervention applied to Left DLPFC located by the BeamF3 technique | Device: Sham or actual non-invasive (Magnetic) brain stimulation<br>* 5 Hz rTMS applied using an actual or sham coil over the left or right DLPFC<br>* Other names: MagStim;|
| Active Comparator: Stimulation of Right DLPFC<br>Intervention applied to Right DLPFC located by the BeamF3 technique | Device: Sham or actual non-invasive (Magnetic) brain stimulation<br>* 5 Hz rTMS applied using an actual or sham coil over the left or right DLPFC<br>* Other names: MagStim;|
| Sham Comparator: Sham Stimulation<br>Sham intervention applied to either the left or right DLPFC | Device: Sham or actual non-invasive (Magnetic) brain stimulation<br>* 5 Hz rTMS applied using an actual or sham coil over the left or right DLPFC<br>* Other names: MagStim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air hunger | Visual analog scale ratings of air hunger | Average of 4 steady state ratings in the last minute of air hunger tests | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood assessment | Bond Lader Mood questionnaire | immediately following pre and post intervention air hunger tests | 
| Trait and state anxiety scores | Spielberger's State-Trait anxiety inventory | immediately following pre and post intervention air hunger tests | 
| Dyspnoea-12 total, physical and emotion scores | Multidimensional D12-Questionnaire | Administered immediately following pre and post intervention air hunger tests in relation to the test just completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Air Hunger