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Study of the Reaction of the Brain to Various Stimulations

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334526
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
Physical activity is considered a therapeutic strategy in its own right in a vast majority of disabling chronic disorders. It leads to an increase in physical and probably cognitive capacity, thanks to its effects on both metabolism (muscle hypertrophy, improvement in oxidative metabolism) and the nervous system (neuroplasticity). Nonetheless, even though there is a consensus on the positive effects of physical exercise (PE) on cerebral plasticity, the physiological mechanisms by which PE affects neuroplasticity, in particular depending on the mode of muscle contraction, are still hypothetical. Moreover, several recent studies have shown that mental learning (ML) by motor imagery improves motor performance, thus making it of interest in a context of rehabilitation, in particular in situations where PE is transient of definitively impossible. Yet, the mechanisms and brain structures involved in motor learning by ML have not been established so far. Finally, on the basis of clinical observations concerning the key role of sensory input in motor function, the hypothesis that increased demand on this input by electrical stimulation (ES) as a means to improve motor function has been proposed. However, the mechanisms by which this type of stimulation could induce neuroplasticity is still to be elucidated.

Condition or disease Intervention/treatment Phase
Corticospinal Plasticity Neuromuscular Plasticity Other: physical training Other: mental training Other: electrical stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: this study is interventional because of it acts on the physical and respiratory capacities of patients
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Corticospinal and Neuromuscular Plasticity Induced by Real and Imaginary Contractions.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: healthy volunteers Other: physical training
workout on treadmill requiring the muscles of the lower limbs mostly in concentric (ascent) or eccentric (downhill)

Other: mental training
The task to imagine for the training group will be an abduction of the thumb

Other: electrical stimulation
electrical stimulation of the muscles




Primary Outcome Measures :
  1. level of corticospinal excitability [ Time Frame: through study completion, an average of 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • persons who have provided written consent
  • healthy subjects
  • national health insurance cover
  • age 18 to 60 years

Exclusion Criteria:

  • personal or family history of epilepsy
  • pacemakers or other apparatus likely to interfere with the magnetic field
  • history of psychiatric disease
  • Persons under guardianship or wards of court
  • Pregnant or breast-feeding women
  • problem perceived during the neurological examination which could bias the results of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334526


Contacts
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Contact: Florent LEBON 3 80 39 67 54 ext +33 florent.lebon@u-bourgogne.fr

Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Contact: Florent LEBON    3 80 39 67 54 ext +33    florent.lebon@u-bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03334526    
Other Study ID Numbers: GREMEAUX 2017
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No