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

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01548586
First received: January 23, 2012
Last updated: October 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Excitability of Diaphragmatic Primary Motor Cortex.
 Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 12
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Magstim 200 TMS(Magstim Company Ltd.UK)

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548586

Locations
France
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
  More Information

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01548586     History of Changes
Other Study ID Numbers: C10-52, 2011-A00508-33
Study First Received: January 23, 2012
Last Updated: October 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
tDCS
Diaphragm
Cortical Excitability
MEPs
TMS

ClinicalTrials.gov processed this record on May 23, 2013