Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation
Investigating the Causal Contribution of Neural Oscillations to Neuromuscular Fatigue After Stroke Using tACS
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
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
- Fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
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
Exclusion Criteria:
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.).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore fittizio: Finto tACS
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mimics active tACS but stops after 1 minute
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Comparatore attivo: Active tACS
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Absolute and relative spectral power and ERD/ERS magnitude
Lasso di tempo: 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.
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Fatigue-related changes in sensorimotor cortical activity will be assessed using EEG-derived absolute and relative spectral power in the mu (8-12 Hz), beta (13-30/35 Hz), and gamma (30/35-100 Hz) frequency bands, as well as changes in event-related desynchronization/event-related synchronization (ERD/ERS) magnitude over time.
Measurements will be obtained at pre-fatigue baseline and continuously during the fatiguing task, with data segmented into contraction epochs and grouped into four fatigue phases for analysis.
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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.
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EMG median frequency
Lasso di tempo: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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Peripheral manifestations of fatigue will be assessed using shifts in EMG median frequency during repeated contractions.
Data will be recorded continuously during the task and analyzed across contraction epochs grouped into four fatigue phases.
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Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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Time-to-task failure (TTF)
Lasso di tempo: Outcome measure will be recorded throughout the fatiguing contractions until exhaustion
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The duration a participant can sustain the prescribed fatiguing exercise until exhaustion
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Outcome measure will be recorded throughout the fatiguing contractions until exhaustion
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Corticomuscular coherence
Lasso di tempo: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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The interaction between cortical and muscular activity will be assessed using CMC, which quantifies synchronization between EEG and EMG signals.
Corticomuscular coherence will be assessed from simultaneous EEG and EMG recordings during repeated contractions and analyzed across contraction epochs grouped into four fatigue phases.
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Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Ictus ischemico
- Ictus
- Fatica
- Terapie
- Discipline e attività comportamentali
- Terapia di stimolazione elettrica
- Terapia convulsiva
- Terapie somatiche psichiatriche
- Elettroshock
- Tecniche psicologiche
- Stimolazione transcranica di corrente continua
Altri numeri di identificazione dello studio
- NMF_STROKe_tACS_FWO
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