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TMS-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants (IMAP-TMS)

I

Institut National de la Santé Et de la Recherche Médicale, France

Status

Enrolling

Conditions

Motor Learning

Treatments

Device: Transcranial magnetic stimulation
Device: Peripheral Nerve Stimulation
Other: Mental training
Other: Physical training
Device: Cervicomedullar stimulation
Device: Robotic arm
Device: Paired Associative Stimulation
Device: Transcranial direct current stimulation
Device: Wrist

Study type

Interventional

Funder types

Other

Identifiers

NCT04784832
2020-A00305-34 / 1 (Registry Identifier)
C19-19

Details and patient eligibility

About

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.

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Enrollment

556 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

556 participants in 28 patient groups

Sequence 1 - Training with same task - Long follow-up
Experimental group
Description:
Motor task (Pretest and Posttests on the same task) Transcranial magnetic stimulation Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 1 - Training with same task - Short follow-up
Experimental group
Description:
Motor task (Pretest and Posttests on the same task) Transcranial magnetic stimulation Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 1 - Training with different tasks - Long follow-up
Experimental group
Description:
Motor task (different task in immediate post test) Transcranial magnetic stimulation Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 1 - Training with different tasks - Short follow-up
Experimental group
Description:
Motor task (different task in immediate post test) Transcranial magnetic stimulation Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 1 - Training with muscle contractions - Long follow-up
Experimental group
Description:
Motor task (isometric muscle contractions in immediate post test) Transcranial magnetic stimulation Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 1 - Training with muscle contractions - Short follow-up
Experimental group
Description:
Motor task (isometric muscle contractions in immediate post test) Transcranial magnetic stimulation Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 1 - Control
Active Comparator group
Description:
Motor task (Pretest and Posttests on the same task) Transcranial magnetic stimulation No mental training
Treatment:
Device: Transcranial magnetic stimulation
Sequence 2 - Physical training with perturbation during preparation - Long follow-up
Active Comparator group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Physical training
Treatment:
Device: Robotic arm
Other: Physical training
Device: Transcranial magnetic stimulation
Sequence 2 - Physical training with perturbation during preparation - Short follow-up
Active Comparator group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Physical training
Treatment:
Device: Robotic arm
Other: Physical training
Device: Transcranial magnetic stimulation
Sequence 2 - Physical training with perturbation after preparation - Long follow-up
Active Comparator group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Physical training
Treatment:
Device: Robotic arm
Other: Physical training
Device: Transcranial magnetic stimulation
Sequence 2 - Physical training with perturbation after preparation - Short follow-up
Active Comparator group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Physical training
Treatment:
Device: Robotic arm
Other: Physical training
Device: Transcranial magnetic stimulation
Sequence 2 - Mental training with perturbation during preparation - Long follow-up
Experimental group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Mental training
Treatment:
Device: Robotic arm
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 2 - Mental training with perturbation during preparation - Short follow-up
Experimental group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Mental training
Treatment:
Device: Robotic arm
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 2 - Mental training with perturbation after preparation - Long follow-up
Experimental group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Mental training
Treatment:
Device: Robotic arm
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 2 - Mental training with perturbation after preparation - Short follow-up
Experimental group
Description:
Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Mental training
Treatment:
Device: Robotic arm
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 3 - Training (same task) - Long follow-up
Experimental group
Description:
Paired Associative Stimulation Mental training (same as the motor task) Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation
Treatment:
Device: Paired Associative Stimulation
Device: Cervicomedullar stimulation
Other: Mental training
Device: Peripheral Nerve Stimulation
Device: Transcranial magnetic stimulation
Sequence 3 - Training (same task) - Short follow-up
Experimental group
Description:
Paired Associative Stimulation Mental training (same as the motor task) Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation
Treatment:
Device: Paired Associative Stimulation
Device: Cervicomedullar stimulation
Other: Mental training
Device: Peripheral Nerve Stimulation
Device: Transcranial magnetic stimulation
Sequence 3 - Training (different task) - Long follow-up
Experimental group
Description:
Paired Associative Stimulation Mental training (different of the motor task) Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation
Treatment:
Device: Paired Associative Stimulation
Device: Cervicomedullar stimulation
Other: Mental training
Device: Peripheral Nerve Stimulation
Device: Transcranial magnetic stimulation
Sequence 3 - Training (different task) - Short follow-up
Experimental group
Description:
Paired Associative Stimulation Mental training (different of the motor task) Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation
Treatment:
Device: Paired Associative Stimulation
Device: Cervicomedullar stimulation
Other: Mental training
Device: Peripheral Nerve Stimulation
Device: Transcranial magnetic stimulation
Sequence 3 - Control 1
Active Comparator group
Description:
Mental Training Motor task (same as the motor task) Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation
Treatment:
Device: Cervicomedullar stimulation
Other: Mental training
Device: Peripheral Nerve Stimulation
Device: Transcranial magnetic stimulation
Sequence 3 - Control 2
Active Comparator group
Description:
Paired Associative Stimulation Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation
Treatment:
Device: Paired Associative Stimulation
Device: Cervicomedullar stimulation
Device: Peripheral Nerve Stimulation
Device: Transcranial magnetic stimulation
Sequence 4 - Immobilization - Short follow-up
Experimental group
Description:
Transcranial magnetic stimulation Arm immobilization Motor task Mental training
Treatment:
Device: Wrist
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 4 - Immobilization - Long follow-up
Experimental group
Description:
Transcranial magnetic stimulation Arm immobilization Motor task Mental training
Treatment:
Device: Wrist
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 4 - Cathodal - Short follow-up
Experimental group
Description:
Transcranial magnetic stimulation Cathodal transcranial direct current stimulation Motor task Mental training
Treatment:
Device: Transcranial direct current stimulation
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 4 - Cathodal - Long follow-up
Experimental group
Description:
Transcranial magnetic stimulation Cathodal transcranial direct current stimulation Motor task Mental training
Treatment:
Device: Transcranial direct current stimulation
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 4 - Anodal - Short follow-up
Experimental group
Description:
Transcranial magnetic stimulation Anodal transcranial direct current stimulation Motor task Mental training
Treatment:
Device: Transcranial direct current stimulation
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 4 - Anodal - Long follow-up
Experimental group
Description:
Transcranial magnetic stimulation Anodal transcranial direct current stimulation Motor task Mental training
Treatment:
Device: Transcranial direct current stimulation
Other: Mental training
Device: Transcranial magnetic stimulation
Sequence 4 - Control
Sham Comparator group
Description:
Transcranial magnetic stimulation Motor task Mental training
Treatment:
Other: Mental training
Device: Transcranial magnetic stimulation
Trial documents
1

Trial contacts and locations

1

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Central trial contact

Florent Lebon, PhD

Data sourced from clinicaltrials.gov

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