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

Oxford Brookes University

Status: Enrolling

Conditions: Dyspnea

Treatments: Device: Sham or actual non-invasive (Magnetic) brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05623696

HLS/2021/PH/002

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups

Stimulation of Left DLPFC

Experimental group

Description:

Intervention applied to Left DLPFC located by the BeamF3 technique

Treatment:

Device: Sham or actual non-invasive (Magnetic) brain stimulation

Stimulation of Right DLPFC

Active Comparator group

Description:

Intervention applied to Right DLPFC located by the BeamF3 technique

Treatment:

Device: Sham or actual non-invasive (Magnetic) brain stimulation

Sham Stimulation

Sham Comparator group

Description:

Sham intervention applied to either the left or right DLPFC

Treatment:

Device: Sham or actual non-invasive (Magnetic) brain stimulation