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

NCT ID: NCT01548586

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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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).

Detailed Description

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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

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Excitability of Diaphragmatic Primary Motor Cortex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Anodal tDCS

Group Type ACTIVE_COMPARATOR

Eldith DC stimulator ( Magstim Company Ltd. UK)

Intervention Type DEVICE

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

Cathodal tDCS

Group Type ACTIVE_COMPARATOR

Eldith DC stimulator ( Magstim Company Ltd. UK)

Intervention Type DEVICE

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

Placebo type tDCS

Group Type PLACEBO_COMPARATOR

Eldith DC stimulator ( Magstim Company Ltd. UK)

Intervention Type DEVICE

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

Interventions

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Eldith DC stimulator ( 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

Intervention Type DEVICE

Other Intervention Names

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Magstim 200 TMS(Magstim Company Ltd.UK)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric AZABOU, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Fréderic LOFASO, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpitaux Universitaires Paris Ile de France Ouest - Hôpital Raymond poincaré

Garches, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 23933029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15634731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20161639 (View on PubMed)

Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.

Reference Type BACKGROUND
PMID: 22085959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16002441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11723286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10990547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19805746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15272049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8756819 (View on PubMed)

Related Links

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https://uvsq.hal.science/hal-02614100v1/document

This paper reports results of this study

https://uvsq.hal.science/hal-01911136/document

This paper reports results of this study

Other Identifiers

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2011-A00508-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

C10-52

Identifier Type: -

Identifier Source: org_study_id

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