Stroke
Conditions
Interventions
Control group:tTIS sham stimulation therapy and conventional rehabilitation therapy.
Experimental group:tTIS real stimulation therapy and conventional rehabilitation therapy.
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. It conforms to the diagnostic criteria for "stroke" in "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019", and has been confirmed by cranial CT or MRI examination; 2. It is the first stroke, with a disease course of >= 1 month; 18 years = 1; 8. Modified Rankin Scale (mRS) score = 22.
Exclusion criteria
Exclusion criteria: 1. Other progressive neurological or somatic diseases: Any other progressive neurological or somatic disease that impairs the function of the affected limb; 2. Moderate to severe hemispatial neglect or anosognosia: Moderate to severe hemispatial neglect or anosognosia involving the affected side of the body; 3. Other neurological diseases: Any other neurological disease that may reduce the safety of participation in the study, including central nervous system vasculitis, intracranial tumors, intracranial aneurysms, multiple sclerosis or arteriovenous malformations; 4. Pain in the affected limb: Pain score in the affected limb >= 5 (based on a 0-10 numerical rating scale, NRS); 5. Severe sensory impairment: A score of 2 on the sensory item of the National Institutes of Health Stroke Scale (NIHSS), indicating severe sensory impairment; 6. Post-stroke epilepsy: Epileptic seizures have occurred since the stroke, regardless of whether antiepileptic drugs are used; 7. Baseline epilepsy or epilepsy history: Diagnosed with potential epilepsy or epilepsy; 8. Recent changes in antispastic drugs or injections: Changed the oral antispastic drug dose within 2 weeks before agreeing to participate in the study, or received botulinum toxin injection in the affected arm within 4 months before agreeing to participate in the study, and/or intended to start using antispastic drugs or receive botulinum toxin injections during the study follow-up; 9. Severe active mental disorders: Existence of major active mental disorders that may interfere with treatment, such as psychotic disorders or severe personality disorders; 10. Untreated or inadequately treated depression: Depression as defined by a Beck Depression Inventory-II (BDI-II) score >= 20 at the time of enrollment; 11. Dementia: Diagnosed with dementia; 12. Chronic uncontrolled hypertension or cardiovascular disease history: Chronic uncontrolled hypertension, or a history of severe and uncontrolled cardiovascular disease; 13. MRI imaging contraindications: For example, incompatible with the scanner weight, implanted metal devices or electronic devices (pacemakers, defibrillators, spinal cord stimulators, etc.); 14. Severe and poorly controlled internal medical conditions: Existence of severe and poorly controlled internal medical conditions, as determined by the principal investigator (PI), due to the expected risks being higher than those of the stroke population, and exclusion is required; 15. Participating in other clinical studies: Has participated in another device, biological agent or drug study before agreeing to participate in this study and has not completed it within 30 days; 16. Pregnancy: Non-pregnant women. Women of reproductive age must use an acceptable contraceptive method. Pregnancy will result in exclusion or withdrawal from the study; 17. Previous bone flap decompression surgery; 18. Previous cerebral vascular interventional stent placement; 19. Small vessel disease or structural abnormalities: Patients have significant chronic small vessel ischemic diseases, vertebrobasilar artery vascular diseases, and/or any other structural abnormalities in the cerebellum, cerebellar peduncles or brainstem; 20. Other risk-increasing or interfering factors: Patients have a certain condition, according to the investigator's opinion, which significantly increases the risk of interfering with study compliance, safety or results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of all serious adverse events from enrollment through the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory-II (BDI-II);Montreal Cognitive Assessment (MoCA);Berg Balance Scale (BBS);Functional MRI (fMRI);Timed Up and Go Test (TUG);Mini-Mental State Examination (MMSE);Brunnstrom classification;EEG-fNIRS;Fugl-Meyer Assessment (FMA) for Upper and Lower Extremity Motor Function;Beck Anxiety Inventory(BAI);Modified Barthel Index (MBI);Modified Ashworth Scale (MAS);Action Research Arm Test (ARAT);Diffusion Tensor Imaging (DTI); | — |
Countries
China
Contacts
Public ContactTang Zhouping
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed