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

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04784832
Collaborator
(none)
300
1
14
72
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial magnetic stimulation
  • Device: Peripheral Nerve Stimulation
  • Device: Transcranial direct current stimulation
  • Device: Paired Associative Stimulation
  • Device: Wrist
  • Device: Robotic arm
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Transcranial Magnetic Stimulation-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Sequence 1 - Control

Motor task (Pretest and Posttests on the same task) Transcranial magnetic stimulation No mental training

Device: Transcranial magnetic stimulation
Magnetic stimulation of the cortex
Other Names:
  • TMS
  • Experimental: Sequence 1 - Training (same Task)

    Motor task (Pretest and Posttests on the same task) Transcranial magnetic stimulation Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Experimental: Sequence 1 - Training (similar task)

    Motor task (Pretest and Posttests with a similar task in immediate post test) Transcranial magnetic stimulation Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Experimental: Sequence 1 - Training (different task)

    Motor task (Pretest and Posttests with a different task in immediate post test) Transcranial magnetic stimulation Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Experimental: Sequence 2 - Mental

    Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Robotic arm
    External perturbation of force field induced by robotic arm

    Experimental: Sequence 2 - Physical

    Motor task (Pretest and Posttests) Transcranial magnetic stimulation External pertubation (robotic arm) Physical training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Robotic arm
    External perturbation of force field induced by robotic arm

    Sham Comparator: Sequence 3 - Control 1

    Mental Training Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Peripheral Nerve Stimulation
    Electric stimulation of the nerves

    Active Comparator: Sequence 3 - Control 2

    Paired Associative Stimulation Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Peripheral Nerve Stimulation
    Electric stimulation of the nerves

    Device: Paired Associative Stimulation
    Combined magnetic and electric stimulation of cortex and nerve, respectively
    Other Names:
  • PAS
  • Experimental: Sequence 3 - Training (same task)

    Paired Associative Stimulation Mental training (one task) Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Peripheral Nerve Stimulation
    Electric stimulation of the nerves

    Device: Paired Associative Stimulation
    Combined magnetic and electric stimulation of cortex and nerve, respectively
    Other Names:
  • PAS
  • Experimental: Sequence 3 - Training (different task)

    Paired Associative Stimulation Mental training (two tasks) Motor task Transcranial magnetic stimulation Peripheral nerve stimulation Cervicomedullar stimulation

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Peripheral Nerve Stimulation
    Electric stimulation of the nerves

    Device: Paired Associative Stimulation
    Combined magnetic and electric stimulation of cortex and nerve, respectively
    Other Names:
  • PAS
  • Sham Comparator: Sequence 4 - Control

    Transcranial magnetic stimulation Motor task Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Experimental: Sequence 4 - Cathodal

    Transcranial magnetic stimulation Cathodal transcranial direct current stimulation Motor task Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Transcranial direct current stimulation
    Electric stimulation of the cortex
    Other Names:
  • tDCS
  • Experimental: Sequence 4 - Anodal

    Transcranial magnetic stimulation Anodal transcranial direct current stimulation Motor task Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Transcranial direct current stimulation
    Electric stimulation of the cortex
    Other Names:
  • tDCS
  • Experimental: Sequence 4 - Immobilization

    Transcranial magnetic stimulation Arm immobilization Motor task Mental training

    Device: Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
    Other Names:
  • TMS
  • Device: Wrist
    Short-term immobilization of the arm

    Outcome Measures

    Primary Outcome Measures

    1. Evolution of movement speed - Sequence 1 [Each day in Sequence 1 (Sequence 1 is 11 days)]

      The duration of performed movement sequences

    2. Evolution of movement accuracy - Sequence 1 [Each day in Sequence 1 (Sequence 1 is 11 days)]

      The accuracy of performed movement sequences (i.e., the correspondence between the performed finger motor sequences and the requested finger motor sequence).

    3. Evolution of trajectory error - Sequence 2 [Each day in Sequence 2 (Sequence 1 is 10 days)]

      The area under the curve of hand's trajectory according to the straight line joining the starting target and the final target.

    4. Evolution of maximal deviation - Sequence 2 [Each day in Sequence 2 (Sequence 1 is 10 days)]

      The maximal perpendicular distance between the position of the hand and the straight line joining the starting target and the final target

    5. Evolution of final error - Sequence 2 [Each day in Sequence 2 (Sequence 1 is 10 days)]

      The distance between the final position of the hand and the position of the final target.

    6. Evolution of movement speed - Sequence 3 [Each day from day 2 to day 11 of Sequence 3 (Sequence 3 is 11 days)]

      The duration of performed movement sequences

    7. Evolution of movement accuracy - Sequence 3 [Each day from day 2 to day 11 of Sequence 3 (Sequence 3 is 11 days)]

      The accuracy of performed movement sequences (i.e., the correspondence between the performed finger motor sequences and the requested finger motor sequence).

    8. Evolution of movement speed - Sequence 4 [Each day in Sequence 4 (Sequence 4 is 6 days)]

      The duration of performed movement sequences

    9. Evolution of movement accuracy - Sequence 4 [Each day in Sequence 4 (Sequence 4 is 6 days)]

      The accuracy of performed movement sequences (i.e., the correspondence between the performed finger motor sequences and the requested finger motor sequence).

    Secondary Outcome Measures

    1. Evolution of motor evoked potentials amplitude- Sequence 1 [Day 1, 5, 6, 10 and 11 in Sequence 1 (Sequence 1 is 11 days).]

      Peak-to-peak amplitude of motor evoked potentials

    2. Evolution of motor evoked potentials amplitude - Sequence 2 [Each day in Sequence 2 (Sequence 2 is 10 days)]

      Peak-to-peak amplitude of motor evoked potentials

    3. Evolution of motor evoked potentials amplitude - Sequence 3 [Day 1, 5, 6, 10 and 11 in Sequence 3 (Sequence 1 is 11 days)]

      Peak-to-peak amplitude of motor evoked potentials

    4. Evolution of motor evoked potentials amplitude - Sequence 4 [Days 1, 5, and 6 in Sequence 4 (Sequence 4 is 6 days)]

      Peak-to-peak amplitude of motor evoked potentials

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    • Perceived 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 or pregnancy.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INSERM - U1093 Cognition, Action, and Sensorimotor Plasticity Dijon France

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Benoit Trojak, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT04784832
    Other Study ID Numbers:
    • C19-19
    • 2020-A00305-34
    First Posted:
    Mar 5, 2021
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 9, 2021