Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation

NCT07613970 | Not Yet Recruiting Phase 1

• 1 other identifier: NMF_STROKe_tACS_FWO
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stroke; Cerebrovascular Accident (CVA); Ischemia Stroke; Hemorrhage Stroke

Keywords

fatigue; electroencephalography; EEG; electromyography; EMG; transcranial alternating current stimulation; tACS

Outcome Measures

Primary Outcomes (3)

• 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.

• Time-to-task failure (TTF)

  The duration a participant can sustain the prescribed fatiguing exercise until exhaustion

  Outcome measure will be recorded throughout the fatiguing contractions until exhaustion

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)

Active tACS

ACTIVE COMPARATOR

Device: Transcranial alternating current stimulation (tACS)

Sham tACS

SHAM COMPARATOR

Device: Sham treatment

Interventions

Transcranial alternating current stimulation (tACS) DEVICE

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.

Active tACS

Sham treatment DEVICE

mimics active tACS but stops after 1 minute

Sham tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05