Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation

Официальное название

Investigating the Causal Contribution of Neural Oscillations to Neuromuscular Fatigue After Stroke Using tACS

Обзор

The goal of this interventional study is to understand the contribution of the central components to the manifestation of neuromuscular fatigue in stroke survivors. The study will include adults with a first-ever stroke in the subacute phase. The main question it aims to answer: • How does the brain activity contribute to the manifestation of neuromuscular fatigue in stroke survivors? Researchers will compare stroke participants receiving active vs sham tACS in a single session before the fatiguing contractions to determine whether central changes can influence fatigue onset/progression. Participants will: * Perform repeated leg muscle contractions until fatigue while seated in an experimental setup * Receive either active or sham tACS for 20 minutes before the fatiguing contractions. * Wear non-invasive sensors to record brain activity (EEG) and muscle activity (EMG) during the task * Complete the study during a single experimental session in which fatigue-related changes will be measured throughout the task

Вмешательства

• Устройство Transcranial alternating current stimulation (tACS)
  Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that uses electrodes on the scalp to apply weak alternating electrical currents to the brain.
• Устройство Sham treatment
  mimics active tACS but stops after 1 minute

Первичные конечные точки

• Absolute and relative spectral power and ERD/ERS magnitude [Срок оценки: Outcome measure will be recorded at baseline and throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.]
• EMG median frequency [Срок оценки: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.]
• Time-to-task failure (TTF) [Срок оценки: Outcome measure will be recorded throughout the fatiguing contractions until exhaustion]

Вторичные конечные точки (1)

• Corticomuscular coherence [Срок оценки: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.]

Критерии участия

Критерии включения

First-ever stroke

≥18 years Subacute phase: 1 week to 6 months post-stroke Quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)) Montreal Cognitive Assessment (MoCA) ≥21

Критерии исключения

History of a previous stroke Severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps/hamstrings) Other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility Non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20) Current or former athletes. Athletes are defined as individuals who participated in organized competitive sports and engaged in structured training ≥3 sessions per week for ≥1 year within the 5 years preceding stroke Contraindications for tACS (e.g., presence of a deep brain stimulator, pacemaker, head wound, etc.).

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

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07613970 · NMF_STROKe_tACS_FWO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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