Skip to main content
OpenTrials
Completed

NCT Number: NCT01892553

Effect of Non Invasive Brain Stimulation on Experimentally Induced Dyspnea (Breathlessness)

Dyspnea is a frequent, mostly unpleasant and long-lasting, but also often undertreated symptom. Transcranial direct current stimulation (tDCS), a new non invasive method to modify brain activation has shown good efficacy in the treatment of pain especially in the clinical context. Given the fact that dyspnea has many common characteristics with pain, especially concerning the brain areas involved in its central processing, we hypothesize that tDCS may also modify the perception of dyspnea. In order to test this, we first shall determine whether tDCS has a significant effect on acutely induced dyspnea in healthy volunteers. In case of promising results of this pilot study, the next step will be the evaluation of the benefit of tDCS in patients with severe dyspnea.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Raymond Poincare

Garches, 92380, France

About this study

Dyspnea will be induced by breathing through a combination of an external resistive load and a long tube (inducing CO2 rebreathing) (resulting in a sensation of both increased respiratory effort and air hunger). tDCS will be applied during 15 minutes either over the motor/premotor or over the insular cortex (i.e. 2 brain regions that have previously been shown to be involved in dyspnea perception and/or modulation) in 2 parallel groups of healthy subjects. For each study group, the effect of tDCS on dyspnea perception and on respiratory parameters will be compared between 2 active (anodal and cathodal) and a sham tDCS stimulation (placebo).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Registered at the National List of persons taking part in clinical research
  • Signed consent form
  • Subjects of both genders aged of at least 18 years
  • Perfect understanding of the instructions and of sensory scaling
  • Prior medical examination

Exclusion criteria

  • Any current or past disease, in particular respiratory, neurological and psychiatric disorders
  • Regular use of drugs, especially those having an impact on respiratory, neurological systems (most specifically those with an effect on the central nervous system)
  • Unwilling to participate
  • Vulnerable people as defined in the provisions relating to biomedical researches and described in the Code of Public Health.
  • Unable to cooperate
  • Pregnancy or lactation
  • No affiliation to a social security system.

Treatment and study plan

tDCS

Device

Procedure : 3 different sessions of tDCS (listed below) presented in random order, each applied at a different study visit

  • Anodal tDCS: Intensity of 1.25 milliAmperes (mA) during 15 min
  • Cathodal tDCS: Intensity of 1.25 mA during 15 min
  • Sham tDCS (placebo) (1.25 mA maintained only during the first 30 sec of the 15 minutes application)

Other names: Eldith DC stimulator (Magstim Company Ltd. UK)

Primary outcomes

  1. Effect of active versus sham tDCS on perceived intensity (sensory component) of induced dyspnea

    Time frame: About 90 min (duration of the study visit)

    Change from baseline (before tDCS application) in intensity of experimentally induced dyspnea (in Borg scale scores) at 4 different time points, 1 during and 3 after each of the 3 tDCS applications (anodal, cathodal and sham)

Secondary outcomes

  1. Effect of active versus sham tDCS on perceived unpleasantness (affective component) of induced dyspnea

    Time frame: About 90 min (duration of the study visit)

    Change from baseline (before tDCS application) in unpleasantness of experimentally induced dyspnea (in Borg scale scores) at 4 different time points, 1 during and 3 after each of the 3 tDCS applications (anodal, cathodal and sham)

  2. Effect of active versus sham tDCS on respiratory variables during induced dyspnea

    Time frame: About 90 min (duration of the study visit)

    Change from baseline (before tDCS application) in mouth pressure swings (cm H2O), tidal volume (L), respiratory frequency (cycles/min), minute ventilation (L/min) and end tidal carbon dioxide (PetCO2)(mm Hg) at 4 different time points, 1 during and 3 after each of the 3 tDCS applications (anodal, cathodal and sham)

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Adep Assistance

Registry information

Official study title

Effect of Transcranial Direct Current Stimulation (tDCS) on Acutely Induced Dyspnea in Healthy Volunteers : a Pilot Study

Acronym: tDCS-Dyspnea

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2013
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.