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

NCT05623696 | Completed

• 1 other identifier: HLS/2021/PH/002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dyspnea

Keywords

Air Hunger

Outcome Measures

Primary Outcomes (1)

• Air hunger

  Ratings of air hunger on a 100mm Visual analog scale with the extremes defined as 'non' and 'tolerable limit'

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

Secondary Outcomes (3)

• Bond Lader Mood questionnaire scores

  Questionnaire administered immediately following pre and post intervention air hunger tests for how participants were feeling at that moment in time.

• Spielberger's state-trait anxiety inventory (STAI form Y-1 and form Y2) scores

  Form Y-2 (trait anxiety) administered once on the initial practice day. Form Y-1 (state anxiety) administered immediately following pre and post intervention air hunger tests on test days.

• Dyspnoea-12 total, physical and emotion scores

  Administered immediately following pre and post intervention air hunger tests in relation to the "test just completed"

Study Arms (3)

Stimulation of Left DLPFC

EXPERIMENTAL

Intervention applied to Left DLPFC located by the BeamF3 technique

Device: rTMS-L-DLPFC

Stimulation of Right DLPFC

ACTIVE COMPARATOR

Intervention applied to Right DLPFC located by the BeamF3 technique

Device: rTMS-R-DLPFC

Sham Stimulation

SHAM COMPARATOR

Sham intervention applied to either the left or right DLPFC

Device: Sham rTMS-DLPFC

Interventions

rTMS-L-DLPFC DEVICE

5 Hz rTMS applied using an actual coil over the left DLPFC

Stimulation of Left DLPFC

rTMS-R-DLPFC DEVICE

5Hz rTMS applied using actual coil over Right DLPFC

Stimulation of Right DLPFC

Sham rTMS-DLPFC DEVICE

5Hz rTMS applied using sham coil over left or right DLPFC

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford Brookes University: lead
• University of Oxford: collaborator

Study Sites (1)

Oxford Brookes University

Oxford, Oxfordshire, OX3 0BP, United Kingdom

Location

Related Publications (6)

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

  BACKGROUND

• 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.

  PMID: 21350791 BACKGROUND

• 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.

  PMID: 33990110 BACKGROUND

• 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.

  PMID: 26134891 BACKGROUND

• 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.

  PMID: 26483701 BACKGROUND

• 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.

  PMID: 19996336 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shakeeb H Moosavi, PhD

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking will only be applied to the participants in relation to whether they receive sham or actual rTMS.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Clinical Physiology

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: February 1, 2022
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the time of submission for journal publication of results
• Access Criteria: RADAR shares the intellectual product of Oxford Brookes University freely and openly, either with staff and students of Oxford brookes University or with the general public and global academic community

Locations

GB (1)