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

Dyspnea Clinical Trial

— tDCS-Dyspnea  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892553
• Other study ID #: acutely2012-A00418-35
• Status: Completed
• Phase: N/A
• First received: July 1, 2013
• Last updated: May 5, 2014
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Dyspnea

Intervention

Device:
• tDCS
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)

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Adep Assistance

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of active versus sham tDCS on perceived intensity (sensory component) of induced dyspnea	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)	About 90 min (duration of the study visit)	No
Secondary	Effect of active versus sham tDCS on perceived unpleasantness (affective component) of induced dyspnea	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)	About 90 min (duration of the study visit)	No
Secondary	Effect of active versus sham tDCS on respiratory variables during induced dyspnea	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)	About 90 min (duration of the study visit)	No