DyspneatDCS-DyspneaNCT01892553
Effect of Non Invasive Brain Stimulation on Experimentally Induced Dyspnea (Breathlessness)
A study testing tDCS in people with Dyspnea, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyspnea
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Acutely Induced Dyspnea in Healthy Volunteers : a Pilot Study
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.
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Eldith DC stimulator (Magstim Company Ltd. UK)
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)
| Study group | Role | What they receive |
|---|---|---|
| motor/premotor cortex stimulation | Experimental | Active and sham tDCS applied over the motor/premotor cortex Receives: Device: tDCS |
| insular cortex stimulation | Experimental | Active and sham tDCS applied over the insular cortex Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: About 90 min (duration of the study visit)
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)
Measured: About 90 min (duration of the study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Adep Assistance
- Responsible party
- Sponsor
- Investigators
- CLAUDINE PEIFFER, MD PHD, Principal investigator, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892553
- Sponsor's protocol ID
- acutely2012-A00418-35
- Acronym
- tDCS-Dyspnea
- Status last verified
- May 2014
- First submitted
- 1 Jul 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation (tDCS) on Acutely Induced Dyspnea in Healthy Volunteers : a Pilot Study
- ClinicalTrials.gov ID
- NCT01892553
- Acronym / sponsor ID
- tDCS-Dyspnea / acutely2012-A00418-35
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Transcranial direct current stimulation (tDCS), Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Adep Assistance
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motor/premotor cortex stimulation | Experimental | Device: tDCSActive and sham tDCS applied over the motor/premotor cortex |
| insular cortex stimulation | Experimental | Device: tDCSActive and sham tDCS applied over the insular cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: Eldith DC stimulator (Magstim Company Ltd. UK)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) | Device | insular cortex stimulation, motor/premotor cortex stimulation |
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)
2 secondary outcomes
Effect of active versus sham tDCS on perceived unpleasantness (affective component) of induced dyspnea
Time frame: About 90 min (duration of the study visit)
Effect of active versus sham tDCS on respiratory variables during induced dyspnea
Time frame: About 90 min (duration of the study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CLAUDINE PEIFFER, MD PHD principal investigator
HOPITAL RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Dyspnea, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of active versus sham tDCS on perceived intensity (sensory component) of induced dyspnea (time frame: About 90 min (duration of the study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.