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Идёт набор NCT04784832

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

Без фазы С лечением Motor Learning

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial magnetic stimulation, Peripheral Nerve Stimulation, Transcranial direct current stimulation, Paired Associative Stimulation.
Кому может быть актуально
Состояния в реестре: Motor Learning. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • INSERM - U1093 Cognition, Action, and Sensorimotor Plasticity — Dijon

Публикации

  • 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

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗