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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05623696
Other study ID # HLS/2021/PH/002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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"
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