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

NCT ID: NCT05623696

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Stimulation of Left DLPFC

Intervention applied to Left DLPFC located by the BeamF3 technique

Group Type: EXPERIMENTAL

Sham or actual non-invasive (Magnetic) brain stimulation

Intervention Type: DEVICE

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

Stimulation of Right DLPFC

Intervention applied to Right DLPFC located by the BeamF3 technique

Group Type: ACTIVE_COMPARATOR

Sham or actual non-invasive (Magnetic) brain stimulation

Intervention Type: DEVICE

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

Sham Stimulation

Sham intervention applied to either the left or right DLPFC

Group Type: SHAM_COMPARATOR

Sham or actual non-invasive (Magnetic) brain stimulation

Intervention Type: DEVICE

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

Interventions

Sham or actual non-invasive (Magnetic) brain stimulation

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

Intervention Type: DEVICE

Other Intervention Names

MagStim

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Oxford Brookes University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shakeeb H Moosavi

Reader in Clinical Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shakeeb H Moosavi, PhD

Role: PRINCIPAL_INVESTIGATOR

Oxford Brookes University

Locations

Oxford Brookes University

Oxford, Oxfordshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Shakeeb H Moosavi, PhD

Role: CONTACT

smoosavi@brookes.ac.uk

+44 (0)7834 083125

Sanjay Kumar, PhD

Role: CONTACT

skumar@brookes.ac.uk

+44 (0)1865 483768 ext. 3768

Facility Contacts

Shakeeb H Moosavi, PhD

Role: primary

smoosavi@brookes.ac.uk

+44 (0)1865 4823257 ext. 3257

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 21350791 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33990110 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26134891 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26483701 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19996336 (View on PubMed)

Other Identifiers

HLS/2021/PH/002

Identifier Type: -

Identifier Source: org_study_id