Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Oxford | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation of Left DLPFC | Experimental | Intervention applied to Left DLPFC located by the BeamF3 technique |
|
| Stimulation of Right DLPFC | Active Comparator | Intervention applied to Right DLPFC located by the BeamF3 technique |
|
| Sham Stimulation | Sham Comparator | Sham intervention applied to either the left or right DLPFC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS-L-DLPFC | Device | 5 Hz rTMS applied using an actual coil over the left DLPFC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Questionnaire administered immediately following pre and post intervention air hunger tests for how participants were feeling at that moment in time. |
Not provided
Inclusion Criteria:
healthy individuals, over 18 years old, with no history of heart, lung or neurological conditions
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shakeeb H Moosavi, PhD | Oxford Brookes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Brookes University | Oxford | Oxfordshire | OX3 0BP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Banzett RB, Moosavi SH. Dyspnea and pain: Similarities and contrasts between two very unpleasant sensations. APS Bulletin. 2001; 11: 1-8. | ||
| 21350791 | 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. | |
| 33990110 |
Not provided
Not provided
The de-identified IPD used in the results publication will be made available on the Oxford Brookes University Research and digital assets repository (RADAR)
At the time of submission for journal publication of results
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
Not provided
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Masking will only be applied to the participants in relation to whether they receive sham or actual rTMS.
| rTMS-R-DLPFC | Device | 5Hz rTMS applied using actual coil over Right DLPFC |
|
| Sham rTMS-DLPFC | Device | 5Hz rTMS applied using sham coil over left or right DLPFC |
|
| 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 | 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 | 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). | Administered immediately following pre and post intervention air hunger tests in relation to the "test just completed" |
| 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. |
| 26134891 | 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. |
| 26483701 | 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. |
| 19996336 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |