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

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT01548586
Collaborator
Assistance Publique - Hôpitaux de Paris (Other)
12
1
3
4
3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
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 Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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)
  • 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)
  • 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)
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpitaux Universitaires Paris Ile de France Ouest - Hôpital Raymond poincaré Garches Ile De France France 92380

    Sponsors and Collaborators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT01548586
    Other Study ID Numbers:
    • C10-52
    • 2011-A00508-33
    First Posted:
    Mar 8, 2012
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France

    Study Results

    No Results Posted as of Sep 1, 2021