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

This study has been completed.
Sponsor:
Collaborator:
Adep Assistance
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01892553
First received: July 1, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Dyspnea
Device: tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Effect of Transcranial Direct Current Stimulation (tDCS) on Acutely Induced Dyspnea in Healthy Volunteers : a Pilot Study

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Effect of active versus sham tDCS on perceived intensity (sensory component) of induced dyspnea [ Time Frame: About 90 min (duration of the study visit) ] [ Designated as safety issue: No ]
    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:
  • Effect of active versus sham tDCS on perceived unpleasantness (affective component) of induced dyspnea [ Time Frame: About 90 min (duration of the study visit) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)


Enrollment: 30
Study Start Date: July 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: motor/premotor cortex stimulation
Active and sham tDCS applied over the motor/premotor cortex
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)
Other Name: Eldith DC stimulator (Magstim Company Ltd. UK)
Experimental: insular cortex stimulation
Active and sham tDCS applied over the insular cortex
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)
Other Name: Eldith DC stimulator (Magstim Company Ltd. UK)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892553

Locations
France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Adep Assistance
Investigators
Principal Investigator: CLAUDINE PEIFFER, MD PHD HOPITAL RAYMOND POINCARE
  More Information

No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01892553     History of Changes
Other Study ID Numbers: acutely2012-A00418-35
Study First Received: July 1, 2013
Last Updated: May 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Dyspnea
Transcranial direct current stimulation (tDCS)
Perception

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014