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Идёт набор NCT07438808

Influence of Physical Exercise on Neuroplasticity and Sensorimotor Networks in Older Adults

Без фазы С лечением tDCS Physical Activity + tDCS Physical Inactivity + tDCS

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: Aerobic Exercise, Physical Inactivity, Transcranial Magnetic Stimulation, transcranial direct current stimulation.
Кому может быть актуально
Состояния в реестре: tDCS, Physical Activity + tDCS, Physical Inactivity + tDCS. Базовые параметры: 20 лет — 80 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 →

Обзор

The purpose of this study is to investigate the influence of a single session of moderate aerobic exercise on motor cortex neuroplasticity in older adults, both alone and in combination with transcranial direct current stimulation (tDCS), and to compare these effects with those observed in young adults. Normal aging is associated with changes in the central nervous system that can affect motor function, sensorimotor integration, and cortical inhibitory mechanisms. These alterations may reduce the brain's capacity for neuroplasticity, which is essential for motor learning and functional adaptation. Physical exercise has been proposed as a potential strategy to counteract age-related decline in neuroplasticity. In this study, healthy young and older adults will participate in three experimental sessions. Participants will complete two experimental conditions in a randomized crossover design: (1) aerobic exercise followed by transcranial direct current stimulation (tDCS), and (2) physical inactivity followed by tDCS and a third session will assess the effects of exercise alone. Moderate aerobic exercise will consist of 20 minutes of cycling on an ergometer. Corticospinal excitability and intracortical and sensorimotor circuit function will be assessed using transcranial magnetic stimulation (TMS) before and after each intervention. Neuroplasticity will be evaluated by measuring changes in motor evoked potentials recorded from a hand muscle of the dominant side. The primary objective is to determine whether aerobic exercise enhances tDCS-induced plasticity, and whether this enhancement differs between young and older adults. Secondary objectives include evaluating age-related differences in intracortical inhibitory and facilitatory mechanisms and sensorimotor integration processes. By improving understanding of how exercise interacts with brain stimulation to modulate motor cortex plasticity, this study may help inform strategies aimed at preserving motor function and functional independence in aging populations.

Подробное описание

Aging is associated with structural and functional changes in the central nervous system that may negatively impact motor control, postural stability, upper-limb coordination, and adaptive motor behavior. These functional alterations are partly attributed to changes in cortical excitability and reduced efficiency of intracortical inhibitory and sensorimotor circuits within the primary motor cortex (M1). Such modifications may contribute to a decline in neuroplasticity, defined as the capacity of the brain to reorganize in response to internal or external stimuli.

Neuroplasticity plays a critical role in motor learning and adaptation and is therefore essential for maintaining functional autonomy in older adults. Identifying interventions capable of enhancing or preserving neuroplasticity with aging represents an important clinical and societal challenge. Aerobic physical exercise has emerged as a promising non-pharmacological strategy to modulate cortical excitability and promote neuroplasticity.

The primary objective of this study is to assess the effect of a single session of moderate aerobic exercise on neuroplasticity induced by transcranial direct current stimulation (tDCS) in older adults, compared with young adults. The secondary objective is to examine the influence of exercise on intrinsic intracortical circuits and sensorimotor integration mechanisms within M1.

Study Design :

This is a monocentric exploratory study where each participant will complete three experimental sessions separated by at least one week :

Session 1 and Session 2 (randomized crossover design):

* Condition A : 20 minutes of moderate aerobic exercise followed by tDCS. * Condition B : 20 minutes of seated rest followed by tDCS. The order of these two conditions will be randomized. Each participant serves as their own control.

Session 3:

* Assessment of the effects of aerobic exercise alone (without tDCS).

Experimental Procedures :

After providing written informed consent, participants undergo baseline assessments including questionnaires documenting physical activity level, handedness, and pain level.

Participants are comfortably seated, and surface electromyography (EMG) electrodes are placed over the abductor pollicis brevis (APB) muscle of the dominant hand. Transcranial magnetic stimulation (TMS) is delivered over M1 corresponding to the dominant hand representation. The optimal stimulation site (hotspot) and resting motor threshold (RMT) are determined.

Corticospinal excitability is assessed using single-pulse TMS at increasing intensities to construct input-output (I/O) recruitment curves. Motor evoked potentials (MEPs) are recorded from the APB muscle. A Boltzmann sigmoidal function is used to model I/O curves and extract parameters including slope, plateau, and S50. The primary outcome measure is the slope of the I/O curve, reflecting corticospinal recruitment gain.

Neuroplasticity is evaluated by comparing corticospinal excitability before and after a 20-minute session of anodal tDCS applied over the dominant M1 (2 mA). Changes in I/O curve parameters after tDCS, with or without prior physical exercise, serve as indicators of induced plasticity.

Intracortical inhibitory and facilitatory mechanisms are assessed using paired-pulse TMS protocols :

* Short-interval intracortical inhibition (SICI) * Intracortical facilitation (ICF) * Long-interval intracortical inhibition (LICI)

Sensorimotor integration is evaluated using paired peripheral nerve stimulation (median nerve at the wrist) combined with TMS to measure :

* Short-latency afferent inhibition (SAI) * Long-latency afferent inhibition (LAI) * Afferent-induced facilitation (AIF) Outcome measures are expressed as ratios of conditioned to unconditioned MEP amplitudes.

Aerobic Exercise Intervention :

Moderate aerobic exercise consists of 20 minutes of cycling on an ergometer at 60 to 70 revolutions per minute. Exercise intensity is individualized to correspond to approximately 50% of heart rate reserve (moderate intensity), monitored throughout the session.

The estimated duration of each experimental session is as follows :

* Session 1 (2h05) : Information, consent, and questionnaires (10 minutes), electrode placement (5 minutes), baseline recordings (35 minutes), 20 minutes of aerobic exercise or seated rest (randomized), 20 minutes of tDCS, and 35 minutes of post-intervention recordings. * Session 2 (1h05) : Same procedure as Session 1 without information, consent, or questionnaires. Participants complete the alternate condition (exercise or rest), followed by tDCS and post-intervention recordings. * Session 3 (1h35) : Preparation (5 minutes), baseline recordings (35 minutes), 20 minutes of aerobic exercise, and 35 minutes of post-exercise recordings.

Вмешательства

  • Поведенческое Aerobic Exercise
    Participants perform 20 minutes of moderate-intensity cycling on a cycle ergometer at 50% of heart rate reserve, maintaining a cadence between 60 and 70 revolutions per minute (rpm).
  • Поведенческое Physical Inactivity
    Participants remain seated for 20 minutes while watching a silent video of natural waterfall scenes without narration.
  • Устройство Transcranial Magnetic Stimulation
    Single- and paired-pulse TMS is applied over the primary motor cortex (M1) to assess corticospinal excitability and intracortical inhibitory and facilitatory mechanisms and sensorimotor circuit function. Motor evoked potentials (MEPs) are recorded from the abductor pollicis brevis (APB) muscle of the dominant hand.
  • Устройство transcranial direct current stimulation
    Anodal transcranial direct current stimulation (tDCS) is delivered for 20 minutes over the primary motor cortex (M1) at a current intensity of 2mA.

Первичные конечные точки

  • Corticospinal excitability [Срок оценки: Assessed at baseline and immediately post-intervention during each of the three experimental sessions (aerobic exercise + tDCS, physical inactivity + tDCS and aerobic exercise alone).]
Вторичные конечные точки (1)
  • Intracortical and sensorimotor circuits of M1 [Срок оценки: Baseline and post-intervention]

Критерии участия

Критерии включения

  • Men or women aged 20 to 35 for the younger group and 65 to 80 for the older group.
  • Healthy right-handed or left-handed subjects.
  • Subjects who have signed an informed consent form.
  • Ability to understand spoken and written French to follow study procedures.
  • Subjects affiliated with or beneficiaries of a social security system.

Критерии исключения

  • History of psychaitric disorders : individuals with mental retardation or severe impairment of cognitive, behavioral, or emotional functions that prevent them from understanding the protocol and signing the informed consent form.
  • Neurological history (epilepsy, stroke, brain or spinal cord surgery, and history of neurological diseases affecting motor skills and sensitivity, such as multiple sclerosis, neurodegenerative diseases such as Parkinson's or Alzheimer's).
  • Inability to give informed consent (e.g., dementia, significant hearing impairment, insufficient language proficiency).
  • Contraindications to TMS and tDCS : uncontrolled epilepsy, intracranial metallic foreign body, hearing aid or cochlear implant, implanted stimulator or pump, scalp skin lesion, high intracranial pressure, cerebrospinal fluid shunt).
  • Presence of a cardiac pacemaker or other implanted electronic medical device.
  • Use of psychotropic drugs.
  • Individuals under legal guardianship or curatorship.
  • Pregnant and breastfeeding women.
  • Inability or recognized contraindication to physical activity.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Eurasport — Loos

Идентификаторы

NCT: NCT07438808 · 2025-A01291-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗