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DyspneaAHrTMSNCT05623696

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

A study testing rTMS-L-DLPFC and rTMS-R-DLPFC in people with Dyspnea, run by Oxford Brookes University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dyspnea
What is being tested?
rTMS-L-DLPFC and rTMS-R-DLPFC
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited Kingdom
Study dates
1 Feb 2022to 16 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Oxford Brookes University

    Oxford, Oxfordshire, OX3 0BP

Other trials in United Kingdom

About this study

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

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
Being tested
rTMS-L-DLPFC, rTMS-R-DLPFC, Sham rTMS-DLPFC
Keywords
Air Hunger
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS-L-DLPFCDevice

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

  • rTMS-R-DLPFCDevice

    5Hz rTMS applied using actual coil over Right DLPFC

  • Sham rTMS-DLPFCDevice

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

Study groups in NCT05623696
Study groupRoleWhat they receive
Stimulation of Left DLPFCExperimentalIntervention applied to Left DLPFC located by the BeamF3 technique
Receives: Device: rTMS-L-DLPFC
Stimulation of Right DLPFCActive comparatorIntervention applied to Right DLPFC located by the BeamF3 technique
Receives: Device: rTMS-R-DLPFC
Sham StimulationSham comparatorSham intervention applied to either the left or right DLPFC
Receives: Device: Sham rTMS-DLPFC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Air hunger

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

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

Secondary outcomes (3)

  1. Bond Lader Mood questionnaire scores

    Ratings provided on a 100mm visual analogue scale anchored by a negative mood descriptor at one extreme and the opposing positive mood descriptor at the other extreme. The average scores for 'sedation' descriptors, 'discontentment' descriptors, and 'relaxation' descriptors are each expressed as %maximum

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

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

    20 is the lowest score and 80 is the highest score for both state (form Y-1) and trait (Form Y-2) anxiety

    Measured: 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.

  3. Dyspnoea-12 total, physical and emotion scores

    For Total score; zero indicates no dyspnoea and 36 indicates worst possible dyspnoea (expressed as %fullscale).

    For Physical score; zero indicates no dyspnoea in the physical domain and 21 indicates worst possible dyspnoea in physical domain (expressed as %fullscale).

    For Emotion score; zero indicates no dyspnoea in emotion domian and 15 indicates worst possible dyspnoea in emotion domain (expressed as %fullscale).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start1 Feb 2022
  3. Primary completion16 May 2024
  4. Study completion16 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623696
Sponsor's protocol ID
HLS/2021/PH/002
Acronym
AHrTMS
Status last verified
Apr 2026
First submitted
12 Nov 2022
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified IPD used in the results publication will be made available on the Oxford Brookes University Research and digital assets repository (RADAR)

Publications

  • 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.

    PubMed 21350791

  • 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.

    PubMed 33990110

  • 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.

    PubMed 26134891

  • 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.

    PubMed 26483701

  • 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.

    PubMed 19996336

Questions about this trial

What is this clinical trial studying?

A study testing rTMS-L-DLPFC and rTMS-R-DLPFC in people with Dyspnea, run by Oxford Brookes University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Air hunger (time frame: Average of 4 steady state ratings in the last minute of air hunger tests). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623696, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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