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Recruiting NCT04784832

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

No phase Interventional Motor Learning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial magnetic stimulation, Peripheral Nerve Stimulation, Transcranial direct current stimulation, Paired Associative Stimulation.
Who it may be relevant to
Registry conditions: Motor Learning. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Transcranial Magnetic Stimulation-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants

Overview

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.

Interventions

  • Device Transcranial magnetic stimulation
    Magnetic stimulation of the cortex
  • Device Peripheral Nerve Stimulation
    Electric stimulation of the nerves
  • Device Transcranial direct current stimulation
    Electric stimulation of the cortex
  • Device Paired Associative Stimulation
    Combined magnetic and electric stimulation of cortex and nerve, respectively
  • Device Wrist
    Short-term immobilization of the arm
  • Device Robotic arm
    External perturbation of force field induced by robotic arm
  • Device Cervicomedullar stimulation
    Electric stimulation of the muscle
  • Other Physical training
    Training to perform the task by actually doing the task
  • Other Mental training
    Training to perform the task by imaging doing the task

Primary outcome measures

  • Evolution of movement speed - Sequence 1 [Time frame: Each day in Sequence 1 (Sequence 1 is 11 days)]
  • Evolution of movement accuracy - Sequence 1 [Time frame: Each day in Sequence 1 (Sequence 1 is 11 days)]
  • Evolution of trajectory error - Sequence 2 [Time frame: Each day in Sequence 2 (Sequence 1 is 10 days)]
  • Evolution of maximal deviation - Sequence 2 [Time frame: Each day in Sequence 2 (Sequence 1 is 10 days)]
  • Evolution of final error - Sequence 2 [Time frame: Each day in Sequence 2 (Sequence 1 is 10 days)]
  • Evolution of movement speed - Sequence 3 [Time frame: Each day from day 2 to day 11 of Sequence 3 (Sequence 3 is 11 days)]
  • Evolution of movement accuracy - Sequence 3 [Time frame: Each day from day 2 to day 11 of Sequence 3 (Sequence 3 is 11 days)]
  • Evolution of movement speed - Sequence 4 [Time frame: Each day in Sequence 4 (Sequence 4 is 6 days)]
  • Evolution of movement accuracy - Sequence 4 [Time frame: Each day in Sequence 4 (Sequence 4 is 6 days)]
Secondary outcome measures (4)
  • Evolution of motor evoked potentials amplitude - Sequence 1 [Time frame: Day 1, 5, 6, 10 and 11 in Sequence 1 (Sequence 1 is 11 days).]
  • Evolution of motor evoked potentials amplitude - Sequence 2 [Time frame: Each day in Sequence 2 (Sequence 2 is 10 days)]
  • Evolution of motor evoked potentials amplitude - Sequence 3 [Time frame: Day 1, 5, 6, 10 and 11 in Sequence 3 (Sequence 1 is 11 days)]
  • Evolution of motor evoked potentials amplitude - Sequence 4 [Time frame: Days 1, 5, and 6 in Sequence 4 (Sequence 4 is 6 days)]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • INSERM - U1093 Cognition, Action, and Sensorimotor Plasticity — Dijon

Publications

  • Abraham WC. Metaplasticity: tuning synapses and networks for plasticity. Nat Rev Neurosci. 2008 May;9(5):387. doi: 10.1038/nrn2356. PMID 18401345
  • Anwar MN, Khan SH. Trial-by-trial adaptation of movements during mental practice under force field. Comput Math Methods Med. 2013;2013:109497. doi: 10.1155/2013/109497. Epub 2013 May 7. PMID 23737857
  • Allami N, Paulignan Y, Brovelli A, Boussaoud D. Visuo-motor learning with combination of different rates of motor imagery and physical practice. Exp Brain Res. 2008 Jan;184(1):105-13. doi: 10.1007/s00221-007-1086-x. Epub 2007 Sep 12. PMID 17849109
  • Arora S, Aggarwal R, Sevdalis N, Moran A, Sirimanna P, Kneebone R, Darzi A. Development and validation of mental practice as a training strategy for laparoscopic surgery. Surg Endosc. 2010 Jan;24(1):179-87. doi: 10.1007/s00464-009-0624-y. Epub 2009 Jul 25. PMID 19633892
  • Avanzino L, Giannini A, Tacchino A, Pelosin E, Ruggeri P, Bove M. Motor imagery influences the execution of repetitive finger opposition movements. Neurosci Lett. 2009 Nov 27;466(1):11-5. doi: 10.1016/j.neulet.2009.09.036. Epub 2009 Sep 20. PMID 19770024
  • Bienenstock EL, Cooper LN, Munro PW. Theory for the development of neuron selectivity: orientation specificity and binocular interaction in visual cortex. J Neurosci. 1982 Jan;2(1):32-48. doi: 10.1523/JNEUROSCI.02-01-00032.1982. PMID 7054394
  • Burianova H, Marstaller L, Sowman P, Tesan G, Rich AN, Williams M, Savage G, Johnson BW. Multimodal functional imaging of motor imagery using a novel paradigm. Neuroimage. 2013 May 1;71:50-8. doi: 10.1016/j.neuroimage.2013.01.001. Epub 2013 Jan 12. PMID 23319043
  • Cantarero G, Tang B, O'Malley R, Salas R, Celnik P. Motor learning interference is proportional to occlusion of LTP-like plasticity. J Neurosci. 2013 Mar 13;33(11):4634-41. doi: 10.1523/JNEUROSCI.4706-12.2013. PMID 23486938

Identifiers

NCT: NCT04784832 · C19-19 · 2020-A00305-34 / 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗