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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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).
Sponsor: Centre d'Investigation Clinique et Technologique 805

Current Primary Outcome: 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)


Original Primary Outcome: Perception of the intensity (sensory component) of induced dyspnea [ Time Frame: About 90 min (duration of the study visit) ]

Determination of the effect of active versus sham tDCS (placebo) on intensity of induced dyspnea. Dyspnea intensity will be rated by the participants before, during and after each of the 3 tDCS applications (anodal, cathodal and sham)


Current Secondary Outcome:

  • 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)
  • 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)


Original Secondary Outcome:

  • Perception of the unpleasantness (affective component) of induced dyspnea [ Time Frame: About 90 min (duration of the study visit) ]
    Determination of the effect of active versus sham tDCS (placebo) on unpleasantness of induced dyspnea. Dyspnea unpleasantness will be rated by the participants before, during and after each of the 3 tDCS applications (anodal, cathodal and sham)
  • Respiratory parameters [ Time Frame: About 90 min (duration of the study visit) ]
    Determination of the effect of active versus sham tDCS (placebo) on respiratory parameters assessed before, during and after each of the 3 tDCS applications (anodal, cathodal and sham)


Information By: Centre d'Investigation Clinique et Technologique 805

Dates:
Date Received: July 1, 2013
Date Started: July 2013
Date Completion:
Last Updated: May 5, 2014
Last Verified: May 2014