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

Not Applicable

Completed

• Conditions: Dyspnea
• Interventions: Device: tDCS

• Registration Number: NCT01892553
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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 Description

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).

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-04
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motor/premotor cortex stimulation	tDCS	Active and sham tDCS applied over the motor/premotor cortex
insular cortex stimulation	tDCS	Active and sham tDCS applied over the insular cortex

Primary Outcome Measures

Name	Time	Method
Effect of active versus sham tDCS on perceived intensity (sensory component) of induced dyspnea	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 Outcome Measures

Name	Time	Method
Effect of active versus sham tDCS on perceived unpleasantness (affective component) of induced dyspnea	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	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)

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France