NCT01892553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

July 1, 2013

Last Update Submit

May 5, 2014

Conditions

Dyspnea

Keywords

DyspneaTranscranial direct current stimulation (tDCS)Perception

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

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

    About 90 min (duration of the study visit)

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

    About 90 min (duration of the study visit)

Study Arms (2)

motor/premotor cortex stimulation

EXPERIMENTAL

Active and sham tDCS applied over the motor/premotor cortex

Device: tDCS

insular cortex stimulation

EXPERIMENTAL

Active and sham tDCS applied over the insular cortex

Device: tDCS

Interventions

tDCSDEVICE

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)

Also known as: Eldith DC stimulator (Magstim Company Ltd. UK)
insular cortex stimulationmotor/premotor cortex stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • CLAUDINE PEIFFER, MD PHD

    HOPITAL RAYMOND POINCARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 4, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

FR(1)