Excitability of Diaphragmatic Primary Motor CortexNCT01548586

Effect of Transcranial Direct Current Stimulation (tDCS) on the Excitability of the Diaphragmatic Primary Motor Cortex

A study testing Eldith DC stimulator ( Magstim Company Ltd. UK) in people with Excitability of Diaphragmatic Primary Motor Cortex, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Excitability of Diaphragmatic Primary Motor Cortex
What is being tested?: Eldith DC stimulator ( Magstim Company Ltd. UK)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteFrance
Study dates: Jan 2012to May 2012
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 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Right handed,
Healthy male volunteers
Aged ≥ 18 and ≤ 35 years
No history of neurological or respiratory disease
BMI (body mass index < 30)

Who cannot join

Female sex
Vulnerable people as defined in the provisions relating to biomedical researches and described in the Code of Public Health.
Recent or ongoing use of antibiotic drugs, antidepressants or psychotropic drugs.
Recent hospitalization (within 3 months).
No affiliation to a social security system.

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpitaux Universitaires Paris Ile de France Ouest - Hôpital Raymond poincaré
Garches, Île-de-France Region, 92380

Other trials in France

About this study

Official title: Modulation de l'excitabilité Des Aires Corticales Motrices Primaires Correspondant Aux hémi Diaphragmes à l'Aide de la tDCS (Transcranial Direct Current Stimulation)

Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to modulate cerebral cortex excitability. It was shown that anodal stimulation increases cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the corticodiaphragmatic pathways. This preliminary study aims to test and validate the modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be assessed before and after applications of three different modalities of tDCS (anodal, cathodal and placebo).

Read the detailed description

We therefore expect to observe a significant increase of the mean values of the right hemidiaphragm's MEP's amplitudes after application of anodal tDCS compared to the baseline MEP obtained before this treatment.

Conditions: Excitability of Diaphragmatic Primary Motor Cortex
Being tested: Eldith DC stimulator ( Magstim Company Ltd. UK)
Keywords: tDCS, Diaphragm, Cortical Excitability, MEPs, TMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eldith DC stimulator ( Magstim Company Ltd. UK)Device
Also called Magstim 200 TMS(Magstim Company Ltd.UK)
Anodal tDCS: Intensity of 2 mA , during 10 min Cathodal tDCS: Intensity of 2 mA , during 10 min Placebo type tDCS: Intensity of 0 mA during 10 min

Study groups in NCT01548586
Study group	Role	What they receive
Anodal tDCS	Active comparator	Not described Receives: Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
Cathodal tDCS	Active comparator	Not described Receives: Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
Placebo type tDCS	Placebo comparator	Not described Receives: Device: Eldith DC stimulator ( Magstim Company Ltd. UK)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the right side hemi-diaphragm's motor evoked potentials (MEPs) before and after applications of three different modalities of tDCS (anodal, cathodal and placebo) upon the left primary motor cortex.
The facilitating effect of tDCS in Anodal stimulation mode (a-tDCS) on the excitability of the left diaphragmatic primary motor cortex would result in a significant increase of the amplitude of the right hemidiaphragm motor evoked potentials (MEPs) (obtained by Transcranial magnetic motor stimulation of the left diaphragmatic primary) after this treatment.
Measured: Baseline MEPs (before tDCS), Post 0 MEPs (immediately after tDCS) and Post 10 MEPs (10 min after tDCS).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012May 2012

First posted8 Mar 2012 (estimated)
Study startJan 2012
Primary completionApr 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Excitability of Diaphragmatic Primary Motor CortexStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01548586
Sponsor's protocol ID: C10-52
Other IDs: 2011-A00508-33
Status last verified: Aug 2021
First submitted: 23 Jan 2012
Last updated: 2 Sep 2025
Results posted: No
Data monitoring committee: No

Publications

Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
PubMed 15634731
Madhavan S, Stinear JW. Focal and bi-directional modulation of lower limb motor cortex using anodal transcranial direct current stimulation. Brain Stimul. 2010 Jan;3(1):42. doi: 10.1016/j.brs.2009.06.005.
PubMed 20161639
Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.
PubMed 22085959
Nitsche MA, Seeber A, Frommann K, Klein CC, Rochford C, Nitsche MS, Fricke K, Liebetanz D, Lang N, Antal A, Paulus W, Tergau F. Modulating parameters of excitability during and after transcranial direct current stimulation of the human motor cortex. J Physiol. 2005 Oct 1;568(Pt 1):291-303. doi: 10.1113/jphysiol.2005.092429. Epub 2005 Jul 7.
PubMed 16002441
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
PubMed 11723286
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547
Roche N, Lackmy A, Achache V, Bussel B, Katz R. Impact of transcranial direct current stimulation on spinal network excitability in humans. J Physiol. 2009 Dec 1;587(Pt 23):5653-64. doi: 10.1113/jphysiol.2009.177550. Epub 2009 Oct 5.
PubMed 19805746
Sharshar T, Hopkinson NS, Jonville S, Prigent H, Carlier R, Dayer MJ, Swallow EB, Lofaso F, Moxham J, Polkey MI. Demonstration of a second rapidly conducting cortico-diaphragmatic pathway in humans. J Physiol. 2004 Nov 1;560(Pt 3):897-908. doi: 10.1113/jphysiol.2004.061150. Epub 2004 Jul 22.
PubMed 15272049
Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41. doi: 10.1164/ajrccm.154.2.8756819.
PubMed 8756819
Azabou E, Roche N, Sharshar T, Bussel B, Lofaso F, Petitjean M. Transcranial direct-current stimulation reduced the excitability of diaphragmatic corticospinal pathways whatever the polarity used. Respir Physiol Neurobiol. 2013 Oct 1;189(1):183-7. doi: 10.1016/j.resp.2013.07.024. Epub 2013 Aug 7.
PubMed 23933029

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation de l'excitabilité Des Aires Corticales Motrices Primaires Correspondant Aux hémi Diaphragmes à l'Aide de la tDCS (Transcranial Direct Current Stimulation)
ClinicalTrials.gov ID: NCT01548586
Acronym / sponsor ID: C10-52
Conditions: Excitability of Diaphragmatic Primary Motor Cortex
Keywords: tDCS, Diaphragm, Cortical Excitability, MEPs, TMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Collaborators: Assistance Publique - Hôpitaux de Paris
Study start: Jan 2012
Primary completion: Apr 2012 (actual)
Study completion: May 2012 (actual)
First posted: 8 Mar 2012 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Anodal tDCS	Active comparator	Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
Cathodal tDCS	Active comparator	Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
Placebo type tDCS	Placebo comparator	Device: Eldith DC stimulator ( Magstim Company Ltd. UK)

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Right handed,
Healthy male volunteers
Aged ≥ 18 and ≤ 35 years
No history of neurological or respiratory disease
BMI (body mass index < 30)

Key exclusion criteria (5 listed)

Female sex
Vulnerable people as defined in the provisions relating to biomedical researches and described in the Code of Public Health.
Recent or ongoing use of antibiotic drugs, antidepressants or psychotropic drugs.
Recent hospitalization (within 3 months).
No affiliation to a social security system.

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
Eldith DC stimulator ( Magstim Company Ltd. UK)Also: Magstim 200 TMS(Magstim Company Ltd.UK)Anodal tDCS: Intensity of 2 mA , during 10 min Cathodal tDCS: Intensity of 2 mA , during 10 min Placebo type tDCS: Intensity of 0 mA during 10 min	Device	Anodal tDCS, Cathodal tDCS, Placebo type tDCS

Primary outcome

Change in the right side hemi-diaphragm's motor evoked potentials (MEPs) before and after applications of three different modalities of tDCS (anodal, cathodal and placebo) upon the left primary motor cortex.
Time frame: Baseline MEPs (before tDCS), Post 0 MEPs (immediately after tDCS) and Post 10 MEPs (10 min after tDCS).
The facilitating effect of tDCS in Anodal stimulation mode (a-tDCS) on the excitability of the left diaphragmatic primary motor cortex would result in a significant increase of the amplitude of the right hemidiaphragm motor evoked potentials (MEPs) (obtained by Transcranial magnetic motor stimulation of the left diaphragmatic primary) after this treatment.

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 2 Sep 2025.
Background: PubMed 15634731Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
Background: PubMed 20161639Madhavan S, Stinear JW. Focal and bi-directional modulation of lower limb motor cortex using anodal transcranial direct current stimulation. Brain Stimul. 2010 Jan;3(1):42. doi: 10.1016/j.brs.2009.06.005.
Background: PubMed 22085959Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.
Background: PubMed 16002441Nitsche MA, Seeber A, Frommann K, Klein CC, Rochford C, Nitsche MS, Fricke K, Liebetanz D, Lang N, Antal A, Paulus W, Tergau F. Modulating parameters of excitability during and after transcranial direct current stimulation of the human motor cortex. J Physiol. 2005 Oct 1;568(Pt 1):291-303. doi: 10.1113/jphysiol.2005.092429. Epub 2005 Jul 7.
Background: PubMed 11723286Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Background: PubMed 19805746Roche N, Lackmy A, Achache V, Bussel B, Katz R. Impact of transcranial direct current stimulation on spinal network excitability in humans. J Physiol. 2009 Dec 1;587(Pt 23):5653-64. doi: 10.1113/jphysiol.2009.177550. Epub 2009 Oct 5.
Background: PubMed 15272049Sharshar T, Hopkinson NS, Jonville S, Prigent H, Carlier R, Dayer MJ, Swallow EB, Lofaso F, Moxham J, Polkey MI. Demonstration of a second rapidly conducting cortico-diaphragmatic pathway in humans. J Physiol. 2004 Nov 1;560(Pt 3):897-908. doi: 10.1113/jphysiol.2004.061150. Epub 2004 Jul 22.
Background: PubMed 8756819Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41. doi: 10.1164/ajrccm.154.2.8756819.
Results publication: PubMed 23933029Azabou E, Roche N, Sharshar T, Bussel B, Lofaso F, Petitjean M. Transcranial direct-current stimulation reduced the excitability of diaphragmatic corticospinal pathways whatever the polarity used. Respir Physiol Neurobiol. 2013 Oct 1;189(1):183-7. doi: 10.1016/j.resp.2013.07.024. Epub 2013 Aug 7.
This paper reports results of this studyLink provided by the sponsor.
This paper reports results of this studyLink provided by the sponsor.

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.

Eric AZABOU, MD principal investigator

Assistance Publique - Hôpitaux de Paris

Fréderic LOFASO, MD, PhD study director

Assistance Publique - Hôpitaux de Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 2 Sep 2025. 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. Some participants in this study may receive a placebo. 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?

Change in the right side hemi-diaphragm's motor evoked potentials (MEPs) before and after applications of three different modalities of tDCS (anodal, cathodal and placebo) upon the left primary motor cortex. (time frame: Baseline MEPs (before tDCS), Post 0 MEPs (immediately after tDCS) and Post 10 MEPs (10 min after tDCS).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01548586, which also lists 10 linked publications.

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 2 Sep 2025.