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

Sponsor
Oxford Brookes University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05623696
Collaborator
University of Oxford (Other)
16
1
3
19.9
0.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sham or actual non-invasive (Magnetic) brain stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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 (Participant)
Masking Description:
Masking will only be applied to the participants in relation to whether they receive sham or actual rTMS.
Primary Purpose:
Basic Science
Official Title:
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex (DLPFC) on Hypercapnic Air Hunger Induced in Healthy Individuals.
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stimulation of Left DLPFC

Intervention applied to Left DLPFC located by the BeamF3 technique

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
Other Names:
  • MagStim
  • Active Comparator: Stimulation of Right DLPFC

    Intervention applied to Right DLPFC located by the BeamF3 technique

    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
    Other Names:
  • MagStim
  • Sham Comparator: Sham Stimulation

    Sham intervention applied to either the left or right DLPFC

    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
    Other Names:
  • MagStim
  • Outcome Measures

    Primary Outcome Measures

    1. Air hunger [Average of 4 steady state ratings in the last minute of air hunger tests]

      Visual analog scale ratings of air hunger

    Secondary Outcome Measures

    1. Mood assessment [immediately following pre and post intervention air hunger tests]

      Bond Lader Mood questionnaire

    2. Trait and state anxiety scores [immediately following pre and post intervention air hunger tests]

      Spielberger's State-Trait anxiety inventory

    3. Dyspnoea-12 total, physical and emotion scores [Administered immediately following pre and post intervention air hunger tests in relation to the "test just completed"]

      Multidimensional D12-Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oxford Brookes University Oxford Oxfordshire United Kingdom OX3 0BP

    Sponsors and Collaborators

    • Oxford Brookes University
    • University of Oxford

    Investigators

    • Principal Investigator: Shakeeb H Moosavi, PhD, Oxford Brookes University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Shakeeb H Moosavi, Reader in Clinical Physiology, Oxford Brookes University
    ClinicalTrials.gov Identifier:
    NCT05623696
    Other Study ID Numbers:
    • HLS/2021/PH/002
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Shakeeb H Moosavi, Reader in Clinical Physiology, Oxford Brookes University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 21, 2022