StrokePhase 1/2NCT07613970
Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation
A Phase 1/2 study testing Transcranial alternating current stimulation (tACS) in people with Stroke and Cerebrovascular Accident (CVA), run by Vrije Universiteit Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebrovascular Accident (CVA), Ischemia Stroke
- What is being tested?
- Transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.).
About this study
Official title: 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:
Read more
- 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
- Being tested
- Transcranial alternating current stimulation (tACS), Sham treatment
- Keywords
- fatigue, electroencephalography, EEG, electromyography, EMG, transcranial alternating current stimulation, tACS
- Medical subject headings
- Stroke, Ischemic Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham treatmentDevice
mimics active tACS but stops after 1 minute
| Study group | Role | What they receive |
|---|---|---|
| Active tACS | Active comparator | Not described Receives: Device: Transcranial alternating current stimulation (tACS) |
| Sham tACS | Sham comparator | Not described Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Outcome measure will be recorded throughout the fatiguing contractions until exhaustion
Secondary 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.
Measured: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613970
- Sponsor's protocol ID
- NMF_STROKe_tACS_FWO
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Causal Contribution of Neural Oscillations to Neuromuscular Fatigue After Stroke Using tACS
- ClinicalTrials.gov ID
- NCT07613970
- Acronym / sponsor ID
- NMF_STROKe_tACS_FWO
- Keywords
- fatigue, electroencephalography, EEG, electromyography, EMG, transcranial alternating current stimulation, tACS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS | Active comparator | Device: Transcranial alternating current stimulation (tACS) |
| Sham tACS | Sham comparator | Device: Sham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active tACS |
| Sham treatmentmimics active tACS but stops after 1 minute | Device | Sham tACS |
Primary outcome
Absolute and relative spectral power and ERD/ERS magnitude
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.
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.
EMG median frequency
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.
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-to-task failure (TTF)
Time frame: Outcome measure will be recorded throughout the fatiguing contractions until exhaustion
The duration a participant can sustain the prescribed fatiguing exercise until exhaustion
1 secondary outcome
Corticomuscular coherence
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial alternating current stimulation (tACS) in people with Stroke and Cerebrovascular Accident (CVA), run by Vrije Universiteit Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute and relative spectral power and ERD/ERS magnitude (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.