Stroke
Conditions
Interventions
TIS Group:The TIS group received true stimulation. The stimulation site was selected as the lower limb motor control area within the ipsilesional M1 area (primary motor cortex) of the patients' brains
the current intensity was controlled within the range of <= 2 mA
and the duration of each stimulation session was 20 minutes. The stimulation treatment protocol was scheduled as once per day, 5 times per week, with a total intervention duration of 2 weeks, and a to
Sham Group:The sham group had electrode placement identical to that of the TIS group, with the same stimulation equipment and procedures utilized. However, a 2 mA current was only applied for 30 secon
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Persistent lower limb motor dysfunction on the affected side caused by a first-ever ischemic/hemorrhagic stroke. 2.Disease duration of 1 -12 months. 3. Age range of 18 - 80 years. 4. Lesions located in the cerebral hemisphere cortex and/or subcortex. 5. Stable vital signs in patients with no progression of neurological symptoms (e.g., normal vital signs including blood pressure, heart rate, and respiratory rate), and no newly developed neurological impairment symptoms such as hemiplegia, aphasia, or altered consciousness, as confirmed by clinical assessment and medical records. 6. No severe aphasia (Boston Diagnostic Aphasia Examination (BDAE) score >= 2 points), no visual or auditory impairments, and ability to complete the study protocol.
Exclusion criteria
Exclusion criteria: 1.A history of brain tumors, traumatic brain injury, hydrocephalus, epilepsy, neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease, etc.) or central nervous system autoimmune diseases, as well as other severe diseases that may affect the study (including cardiopulmonary, liver, and kidney diseases, etc.). 2. Imaging examinations showing large-area structural damage to the affected side of M1 (e.g., complete infarction) or active abnormal signals in the lesion area (e.g., unabsorbed hematoma, edema, or gliosis). 3. Presence of metal/electronic implants in the cranium, skull, or orbit (e.g., deep brain stimulation electrodes, skull repair plates, subdural/epidural electrode grids, aneurysm clips, ventriculoperitoneal shunts, etc.) or implanted electronic devices in the body (e.g., cardiac pacemakers, cochlear implants). 4. Presence of severe somatosensory impairment/apraxia/cognitive impairment. 5. Post-craniotomy/skull defect. 6. Lesions in the cerebellum or brainstem. 7. Receipt of botulinum toxin injection within the past 3 months, with the injection site being the affected lower limb. 8. Other severe diseases that may affect the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment: Lower Extremity Component;Montreal Cognitive Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Motricity Index-Lower Extremity;Berg Balance Scale;Digit span;Stroop Color - Word Test;Electroencephalographic absolute power;Electroencephalographic relative power;Electroencephalographic Delta/Alpha Ratio;Electroencephalographic Delta-Theta/Alpha-Beta Ratio;Electroencephalogram Weighted Phase Lag Index;Electroencephalographic Partial Directed Coherence;Resting-state functional connectivity of functional near-infrared spectroscopy;Fractional amplitude of low-frequency fluctuations of functional near-infrared spectroscopy; | — |
Countries
China
Contacts
Public ContactHu Xiquan
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed