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

August 25, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cathodal tDCS
Device: 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
Other Names:
  • Magstim 200 TMS(Magstim Company Ltd.UK)
Active Comparator: Anodal tDCS
Device: 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
Other Names:
  • Magstim 200 TMS(Magstim Company Ltd.UK)
Placebo Comparator: Placebo type tDCS
Device: 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
Other Names:
  • Magstim 200 TMS(Magstim Company Ltd.UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline MEPs (before tDCS), Post 0 MEPs (immediately after tDCS) and Post 10 MEPs (10 min after tDCS).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Eric AZABOU, MD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Fréderic LOFASO, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimated)

March 8, 2012

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C10-52
  • 2011-A00508-33 (Registry Identifier: Numéro IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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