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

Dyspnea Clinical Trial

— AHrTMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623696
• Other study ID #: HLS/2021/PH/002
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: Oxford Brookes University
• Contact: Shakeeb H Moosavi, PhD
• Phone: +44 (0)7834 083125
• Email: smoosavi[@]brookes.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyspnea

Intervention

Device:
• Sham or actual non-invasive (Magnetic) brain stimulation
5 Hz rTMS applied using an actual or sham coil over the left or right DLPFC

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes University	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Brookes University	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Banzett RB, Moosavi SH. Dyspnea and pain: Similarities and contrasts between two very unpleasant sensations. APS Bulletin. 2001; 11: 1-8.

Brighina F, De Tommaso M, Giglia F, Scalia S, Cosentino G, Puma A, Panetta M, Giglia G, Fierro B. Modulation of pain perception by transcranial magnetic stimulation of left prefrontal cortex. J Headache Pain. 2011 Apr;12(2):185-91. doi: 10.1007/s10194-011-0322-8. Epub 2011 Feb 25. — View Citation

Harrison OK, Hayen A, Wager TD, Pattinson KTS. Investigating the specificity of the neurologic pain signature against breathlessness and finger opposition. Pain. 2021 Dec 1;162(12):2933-2944. doi: 10.1097/j.pain.0000000000002327. — View Citation

Herigstad M, Hayen A, Evans E, Hardinge FM, Davies RJ, Wiech K, Pattinson KTS. Dyspnea-related cues engage the prefrontal cortex: evidence from functional brain imaging in COPD. Chest. 2015 Oct;148(4):953-961. doi: 10.1378/chest.15-0416. — View Citation

Nierat MC, Hudson AL, Chaskalovic J, Similowski T, Laviolette L. Repetitive transcranial magnetic stimulation over the supplementary motor area modifies breathing pattern in response to inspiratory loading in normal humans. Front Physiol. 2015 Sep 29;6:273. doi: 10.3389/fphys.2015.00273. eCollection 2015. — View Citation

Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010 Jan;65(1):21-6. doi: 10.1136/thx.2009.118521. Epub 2009 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Air hunger	Visual analog scale ratings of air hunger	Average of 4 steady state ratings in the last minute of air hunger tests
Secondary	Mood assessment	Bond Lader Mood questionnaire	immediately following pre and post intervention air hunger tests
Secondary	Trait and state anxiety scores	Spielberger's State-Trait anxiety inventory	immediately following pre and post intervention air hunger tests
Secondary	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"