Corticospinal PlasticityNCT03334526
Study of the Reaction of the Brain to Various Stimulations
A study testing physical training, mental training and electrical stimulation in people with Corticospinal Plasticity and Neuromuscular Plasticity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Corticospinal Plasticity, Neuromuscular Plasticity
- What is being tested?
- physical training, mental training and electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2017to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- persons who have provided written consent
- healthy subjects
- national health insurance cover
- age 18 to 60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Corticospinal Plasticity, Neuromuscular Plasticity
- Being tested
- physical training, mental training, electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingOther
workout on treadmill requiring the muscles of the lower limbs mostly in concentric (ascent) or eccentric (downhill)
mental trainingOther
The task to imagine for the training group will be an abduction of the thumb
electrical stimulationOther
electrical stimulation of the muscles
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Other: physical training; Other: mental training; Other: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of corticospinal excitability
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start9 Nov 2017
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corticospinal PlasticityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- this study is interventional because of it acts on the physical and respiratory capacities of patients
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334526
- Sponsor's protocol ID
- GREMEAUX 2017
- Status last verified
- Feb 2023
- First submitted
- 13 Oct 2017
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dupont W, Papaxanthis C, Lurquin L, Lebon F, Madden-Lombardi C. Negated actions are simulated within the primary motor cortex. Neuroscience. 2025 Jan 26;565:468-478. doi: 10.1016/j.neuroscience.2024.12.018. Epub 2024 Dec 12.
PubMed 39674536Dupont W, Papaxanthis C, Lebon F, Madden-Lombardi C. Mental Simulations and Action Language Are Impaired in Individuals with Aphantasia. J Cogn Neurosci. 2024 Feb 1;36(2):261-271. doi: 10.1162/jocn_a_02084.
PubMed 37944123
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticospinal and Neuromuscular Plasticity Induced by Real and Imaginary Contractions.
- ClinicalTrials.gov ID
- NCT03334526
- Acronym / sponsor ID
- GREMEAUX 2017
- Conditions
- Corticospinal Plasticity, Neuromuscular Plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- this study is interventional because of it acts on the physical and respiratory capacities of patients
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: physical training, Other: mental training, Other: electrical stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- persons who have provided written consent
- healthy subjects
- national health insurance cover
- age 18 to 60 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical trainingworkout on treadmill requiring the muscles of the lower limbs mostly in concentric (ascent) or eccentric (downhill) | Other | healthy volunteers |
| mental trainingThe task to imagine for the training group will be an abduction of the thumb | Other | healthy volunteers |
| electrical stimulationelectrical stimulation of the muscles | Other | healthy volunteers |
Primary outcome
level of corticospinal excitability
Time frame: through study completion, an average of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 39674536Dupont W, Papaxanthis C, Lurquin L, Lebon F, Madden-Lombardi C. Negated actions are simulated within the primary motor cortex. Neuroscience. 2025 Jan 26;565:468-478. doi: 10.1016/j.neuroscience.2024.12.018. Epub 2024 Dec 12.
- Derived from this study: PubMed 37944123Dupont W, Papaxanthis C, Lebon F, Madden-Lombardi C. Mental Simulations and Action Language Are Impaired in Individuals with Aphantasia. J Cogn Neurosci. 2024 Feb 1;36(2):261-271. doi: 10.1162/jocn_a_02084.
Related trials for Corticospinal Plasticity
Recruiting
Spinal Cord Associative Plasticity in Cerebral Palsy
Hemiplegic Cerebral Palsy
Recruiting
Cervical Spinal Cord Associative Plasticity
Cervical Spinal Cord Plasticity
RecruitingEarly Phase 1
MEP Up-conditioning to Target Corticospinal Plasticity
Spinal Cord Injury, Tetraplegia/Tetraparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical training, mental training and electrical stimulation in people with Corticospinal Plasticity and Neuromuscular Plasticity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of corticospinal excitability (time frame: through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.