NCT07594938

Brief Summary

The goal of this observational study is to learn how neuromuscular fatigue develops after stroke and how changes in brain activity, muscle activity, and their interaction contribute to reduced motor performance in stroke survivors compared to healthy individuals. The study will include adults with a first-ever stroke in the subacute phase and age-matched healthy volunteers. The main questions it aims to answer are:

  • How does neuromuscular fatigue develop during repeated muscle contractions after stroke compared to healthy individuals?
  • How do brain activity, muscle activity, and brain-muscle interaction change during fatigue after stroke? Researchers will compare stroke participants and healthy control participants to determine whether fatigue-related changes are more strongly associated with altered brain activity, altered muscle activity, or disrupted brain-muscle communication after stroke. Participants will:
  • Perform repeated leg muscle contractions until fatigue while seated in an experimental setup
  • 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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
39mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

May 11, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

fatigueelectroencephalographyEEGelectromyographyEMGstroke

Outcome Measures

Primary Outcomes (2)

  • Absolute and relative spectral power and ERD/ERS magnitude

    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

    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.

Secondary Outcomes (1)

  • Corticomuscular coherence

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

Study Arms (2)

Subacute stroke

Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included. Exclusion criteria include a 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), and current or former athletes.

Healthy participants

Healthy age-matched controls ≥18 years and Montreal Cognitive Assessment (MoCA) ≥21 will be included. Exclusion criteria include 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), and current or former athletes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Healthy, age-matched controls will be recruited through our research group's network and residential care homes in Belgium.

You may qualify if:

  • Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeIschemic StrokeFatigue

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 19, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 31, 2029

Study Completion (Estimated)

October 31, 2029

Last Updated

May 19, 2026

Record last verified: 2026-05