Completed

NCT Number: NCT01548586

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

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).

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Key information

Conditions

Excitability of Diaphragmatic Primary Motor Cortex

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires Paris Ile de France Ouest - Hôpital Raymond poincaré

Garches, Île-de-France Region, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eldith DC stimulator ( Magstim Company Ltd. UK)

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

Other names: Magstim 200 TMS(Magstim Company Ltd.UK)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 8, 2012
Registry last updated: Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.