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

Primary Purpose

Dyspnea

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sham or actual non-invasive (Magnetic) brain stimulation
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyspnea focused on measuring Air Hunger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oxford Brookes UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Stimulation of Left DLPFC

Stimulation of Right DLPFC

Sham Stimulation

Arm Description

Intervention applied to Left DLPFC located by the BeamF3 technique

Intervention applied to Right DLPFC located by the BeamF3 technique

Sham intervention applied to either the left or right DLPFC

Outcomes

Primary Outcome Measures

Air hunger
Visual analog scale ratings of air hunger

Secondary Outcome Measures

Mood assessment
Bond Lader Mood questionnaire
Trait and state anxiety scores
Spielberger's State-Trait anxiety inventory
Dyspnoea-12 total, physical and emotion scores
Multidimensional D12-Questionnaire

Full Information

First Posted
November 12, 2022
Last Updated
November 12, 2022
Sponsor
Oxford Brookes University
Collaborators
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05623696
Brief Title
Effect of Non-invasive Magnetic Stimulation of the Brain on Breathlessness in Healthy Individuals.
Acronym
AHrTMS
Official Title
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex (DLPFC) on Hypercapnic Air Hunger Induced in Healthy Individuals.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
Collaborators
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Air Hunger

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
Masking will only be applied to the participants in relation to whether they receive sham or actual rTMS.
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation of Left DLPFC
Arm Type
Experimental
Arm Description
Intervention applied to Left DLPFC located by the BeamF3 technique
Arm Title
Stimulation of Right DLPFC
Arm Type
Active Comparator
Arm Description
Intervention applied to Right DLPFC located by the BeamF3 technique
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Sham intervention applied to either the left or right DLPFC
Intervention Type
Device
Intervention Name(s)
Sham or actual non-invasive (Magnetic) brain stimulation
Other Intervention Name(s)
MagStim
Intervention Description
5 Hz rTMS applied using an actual or sham coil over the left or right DLPFC
Primary Outcome Measure Information:
Title
Air hunger
Description
Visual analog scale ratings of air hunger
Time Frame
Average of 4 steady state ratings in the last minute of air hunger tests
Secondary Outcome Measure Information:
Title
Mood assessment
Description
Bond Lader Mood questionnaire
Time Frame
immediately following pre and post intervention air hunger tests
Title
Trait and state anxiety scores
Description
Spielberger's State-Trait anxiety inventory
Time Frame
immediately following pre and post intervention air hunger tests
Title
Dyspnoea-12 total, physical and emotion scores
Description
Multidimensional D12-Questionnaire
Time Frame
Administered immediately following pre and post intervention air hunger tests in relation to the "test just completed"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shakeeb H Moosavi, PhD
Phone
+44 (0)7834 083125
Email
smoosavi@brookes.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay Kumar, PhD
Phone
+44 (0)1865 483768
Ext
3768
Email
skumar@brookes.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakeeb H Moosavi, PhD
Organizational Affiliation
Oxford Brookes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Brookes University
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 0BP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shakeeb H Moosavi, PhD
Phone
+44 (0)1865 4823257
Ext
3257
Email
smoosavi@brookes.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Banzett RB, Moosavi SH. Dyspnea and pain: Similarities and contrasts between two very unpleasant sensations. APS Bulletin. 2001; 11: 1-8.
Results Reference
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PubMed Identifier
21350791
Citation
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.
Results Reference
background
PubMed Identifier
33990110
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.
Results Reference
background
PubMed Identifier
26134891
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.
Results Reference
background
PubMed Identifier
26483701
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.
Results Reference
background
PubMed Identifier
19996336
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.
Results Reference
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Effect of Non-invasive Magnetic Stimulation of the Brain on Breathlessness in Healthy Individuals.

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