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Not yet recruiting NCT07613970

Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation

Phase I / Phase II Interventional Stroke Cerebrovascular Accident (CVA) Ischemia Stroke Hemorrhage Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial alternating current stimulation (tACS), Sham treatment.
Who it may be relevant to
Registry conditions: Stroke, Cerebrovascular Accident (CVA), Ischemia Stroke, Hemorrhage Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigating the Causal Contribution of Neural Oscillations to Neuromuscular Fatigue After Stroke Using tACS

Overview

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

Interventions

  • Device 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 Sham treatment
    mimics active tACS but stops after 1 minute

Primary outcome measures

  • 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.]
  • 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.]
  • Time-to-task failure (TTF) [Time frame: Outcome measure will be recorded throughout the fatiguing contractions until exhaustion]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07613970 · NMF_STROKe_tACS_FWO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗