- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03334526
Study of the Reaction of the Brain to Various Stimulations
February 15, 2023 updated by: Centre Hospitalier Universitaire Dijon
Corticospinal and Neuromuscular Plasticity Induced by Real and Imaginary Contractions.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
174
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
-
-
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Dijon, France, 21079
- CHU Dijon Bourgogne
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: healthy volunteers
|
workout on treadmill requiring the muscles of the lower limbs mostly in concentric (ascent) or eccentric (downhill)
The task to imagine for the training group will be an abduction of the thumb
electrical stimulation of the muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
level of corticospinal excitability
Time Frame: through study completion, an average of 4 years
|
through study completion, an average of 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
November 9, 2017
Primary Completion (Actual)
June 24, 2022
Study Completion (Actual)
June 24, 2022
Study Registration Dates
First Submitted
October 13, 2017
First Submitted That Met QC Criteria
November 2, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Estimate)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GREMEAUX 2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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