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Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation

21. mai 2026 oppdatert av: Vrije Universiteit Brussel

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Fase 2
  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: Sham tACS
Enhet: Sham treatment
mimics active tACS but stops after 1 minute
Aktiv komparator: Active tACS
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Absolute and relative spectral power and ERD/ERS magnitude
Tidsramme: 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.
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.
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
Tidsramme: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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.
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)
Tidsramme: Outcome measure will be recorded throughout the fatiguing contractions until exhaustion
The duration a participant can sustain the prescribed fatiguing exercise until exhaustion
Outcome measure will be recorded throughout the fatiguing contractions until exhaustion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Corticomuscular coherence
Tidsramme: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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.
Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vrije Universiteit Brussel

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. oktober 2029

Studiet fullført (Antatt)

31. oktober 2029

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NMF_STROKe_tACS_FWO

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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