Clinical trial NCT04784832: TMS-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants
Official title: Transcranial Magnetic Stimulation-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motor Learning
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2021-03-05
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The general purpose of this research project is to analyze the specific role of motor imagery on motor learning, assessed through corticospinal excitability measurements and behavioral data collection. This project is based on four sequences. For Sequence 1, the main objective is to examine the effect of mental training on movement speed and accuracy in a manual motor sequence task, as well as the influence of sensory feedback in immediate post-test (i.e., execution of a similar, but not identical, manual motor sequence, other manual tasks) on performance in delayed post-test. The secondary objective will be to examine corticospinal changes (i.e., amplitude of motor evoked potentials) induced by mental training, by measuring the amplitude of motor evoked potentials before and after mental training. For Sequence 2, the main objective is to examine the impact of a motor disturbance induced by a robotic arm at different intervals during the motor imagery process. The secondary objective will be to examine the corticospinal changes (i.e. amplitude of evoked motor potentials) induced by mental training as a function of the applied perturbations, before and after perturbation. For Sequence 3, the main objective will be to examine the influence of neuroplasticity on the quality of mental training. More specifically, the investigators will study the links between brain plasticity and motor learning through mental training. The secondary objective will be to examine the corticospinal changes (i.e. amplitude of evoked motor potentials) induced by mental training at different levels of the neuromuscular system (cortical, cervicomedullar, peripheral) after a training period. For Sequence 4, the main objective will be to examine the effect of short-term arm-immobilization of on the retention of motor learning induced by mental training. The secondary objective will be to examine the corticospinal changes (i.e., amplitude of motor evoked potentials) induced by of short-term arm-immobilization, or by transcranial direct current stimulation (tDCS), on motor learning. The results of this fundamental research project will allow a better understanding of neurophysiological and behavioral mechanisms that underlie motor learning through motor imagery. The results will allow to efficiently consider inter-individual specificities and will thus open up to clinical research perspectives, towards the establishment of adapted motor rehabilitation protocols.


Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 60 years old
* Having given written informed consent
* Affiliated to a social security scheme

Exclusion Criteria:

* History of psychiatric illness (declarative)
* Person under guardianship, curatorship, safeguard of justice
* Neurological problem that could bias the results of the study (declarative)
* Personal or family history of epilepsy
* Person deprived of liberty by judicial or administrative decision
* Person hospitalized without consent and not subject to legal protection, and person admitted to a health or social institution for purposes other than that of the research
* Person subject to an exclusion period for another research
* Pregnant women or women of childbearing age not using known contraception
* Breastfeeding women
* Person on medication that could influence neurophysiological measures (neuroleptics, anxiolytics, antidepressants)
* Person carrying :
* pacemaker or other device that could interfere with the magnetic field
* Implants (mechanical or electronic: cochlear implants, neural or cardiac pacemakers, infusion pumps, magnetic aneurysm clips, etc.)
* Metallic foreign bodies in the eye or nervous system
* Metallic objects (tattoos, piercings, etc.)

Primary outcomes:
measure: Evolution of movement speed - Sequence 1
timeFrame: Each day in Sequence 1 (Sequence 1 is 11 days)
measure: Evolution of movement accuracy - Sequence 1
timeFrame: Each day in Sequence 1 (Sequence 1 is 11 days)
measure: Evolution of trajectory error - Sequence 2
timeFrame: Each day in Sequence 2 (Sequence 1 is 10 days)
measure: Evolution of maximal deviation - Sequence 2
timeFrame: Each day in Sequence 2 (Sequence 1 is 10 days)
measure: Evolution of final error - Sequence 2
timeFrame: Each day in Sequence 2 (Sequence 1 is 10 days)
measure: Evolution of movement speed - Sequence 3
timeFrame: Each day from day 2 to day 11 of Sequence 3 (Sequence 3 is 11 days)
measure: Evolution of movement accuracy - Sequence 3
timeFrame: Each day from day 2 to day 11 of Sequence 3 (Sequence 3 is 11 days)
measure: Evolution of movement speed - Sequence 4
timeFrame: Each day in Sequence 4 (Sequence 4 is 6 days)
measure: Evolution of movement accuracy - Sequence 4
timeFrame: Each day in Sequence 4 (Sequence 4 is 6 days)
Secondary outcomes:
measure: Evolution of motor evoked potentials amplitude - Sequence 1
timeFrame: Day 1, 5, 6, 10 and 11 in Sequence 1 (Sequence 1 is 11 days).
measure: Evolution of motor evoked potentials amplitude - Sequence 2
timeFrame: Each day in Sequence 2 (Sequence 2 is 10 days)
measure: Evolution of motor evoked potentials amplitude - Sequence 3
timeFrame: Day 1, 5, 6, 10 and 11 in Sequence 3 (Sequence 1 is 11 days)
measure: Evolution of motor evoked potentials amplitude - Sequence 4
timeFrame: Days 1, 5, and 6 in Sequence 4 (Sequence 4 is 6 days)
Other outcomes:
Locations:
city: Dijon
country: France
facility: INSERM - U1093 Cognition, Action, and Sensorimotor Plasticity
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Florent Lebon, PhD
role: PRINCIPAL_INVESTIGATOR
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