Clinical trial NCT01548586: Effect of Transcranial Direct Current Stimulation (tDCS) on the Excitability of the Diaphragmatic Primary Motor Cortex
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excitability of Diaphragmatic Primary Motor Cortex
Keywords: tDCS
Diaphragm
Cortical Excitability
MEPs
TMS
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2012-03-08
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Baseline MEPs (before tDCS), Post 0 MEPs (immediately after tDCS) and Post 10 MEPs (10 min after tDCS).
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpitaux Universitaires Paris Ile de France Ouest - Hôpital Raymond poincaré
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Eric AZABOU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Fréderic LOFASO, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
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