Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVrije Universiteit Brussel
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Transcranial alternating current stimulation (tACS)
DeviceTranscranial 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.
Sham treatment
Devicemimics active tACS but stops after 1 minute
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Active tACSActive comparator 1 intervention
Group B: Sham tACSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.2
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.
Time frame
Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.3
Time-to-task failure (TTF)
The duration a participant can sustain the prescribed fatiguing exercise until exhaustion
Time frame
Outcome measure will be recorded throughout the fatiguing contractions until exhaustionSecondary outcomes
1
Corticomuscular coherence
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.
Time frame
Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: