ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01548586
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : October 8, 2012
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

January 23, 2012
March 8, 2012
October 8, 2012
January 2012
April 2012   (Final data collection date for primary outcome 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. [ 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.
Same as current
Complete list of historical versions of study NCT01548586 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Transcranial Direct Current Stimulation (tDCS) on the Excitability of the Diaphragmatic Primary Motor Cortex
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).
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Excitability of Diaphragmatic Primary Motor Cortex.
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: Anodal tDCS
    Intervention: Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
  • Active Comparator: Cathodal tDCS
    Intervention: Device: Eldith DC stimulator ( Magstim Company Ltd. UK)
  • Placebo Comparator: Placebo type tDCS
    Intervention: Device: Eldith DC stimulator ( Magstim Company Ltd. UK)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
May 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01548586
C10-52
2011-A00508-33 ( Registry Identifier: Numéro IDRCB )
No
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Eric AZABOU, MD Assistance Publique - Hôpitaux de Paris
Study Director: Fréderic LOFASO, MD, PhD Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP