cerebral infarction
Conditions
Interventions
subjects:Participants underwent five intervention sessions per week for a total of four weeks, amounting to 20 sessions. Each intervention session comprised two 40-minute tTIS sessions targeting the c
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for "Stroke" as defined in Diagnostic Essentials for Major Cerebrovascular Diseases in China 2019, confirmed by cranial CT or MRI; 2.First-ever stroke, with disease duration between 1 and 3 years; 3.Age between 18 and 70 years; 4.Unilateral ischemic stroke in the middle cerebral artery (MCA) territory, without involvement of the cerebellum, thalamus, or brainstem; 5.Presence of a standard physiological motor pathway response, defined as an image-guided, transcranial magnetic stimulation (TMS)-induced motor evoked potential (MEP) with a peak-to-peak amplitude of 50–100 µV (in at least 5 out of 10 trials) in either the paretic extensor digitorum communis (EDC) or proximal musculature (including forearm or wrist flexors) during partial contraction (20–50% of maximum voluntary contraction); 6.Medically and neurologically stable: Determined by the investigator based on medical history, physical examination, and neurological examination; 7.Residual moderate-to-severe unilateral upper limb hemiparesis: Defined as a score of =1 on the FMA-UE sub-items for elbow flexion, elbow extension, or finger grasping; 9.Modified Rankin Scale (mRS) score =24.
Exclusion criteria
Exclusion criteria: 1. Primary haemorrhagic stroke or severe haemorrhagic transformation; 2. Other progressive neurological or systemic diseases: any progressive neurological or systemic disease, other than stroke, that impairs the function of the target limb; 3. Moderate to severe hemispatial neglect or agnosia: moderate to severe hemispatial neglect or agnosia affecting the affected side of the body; 4. Other neurological conditions: the presence of any other neurological condition that may compromise the safety of study participation, including central nervous system vasculitis, intracranial tumours, intracranial aneurysms, multiple sclerosis or arteriovenous malformations; 5. Pain in the affected limb: pain score in the affected limb >=5 (based on a 0–10 numerical rating scale, NRS); 6. Severe sensory impairment: A score of 2 on the sensory subscale (item 8) of the National Institutes of Health Stroke Scale (NIHSS), indicating severe sensory impairment; 7. Post-stroke seizures: Seizures have occurred since the onset of the stroke, regardless of whether antiepileptic medication is being used; 8. Underlying epilepsy or history of epilepsy: Diagnosis of an underlying seizure disorder or epilepsy; 9. Recent changes to or injections of anticonvulsant medication: A change in the dose of oral anticonvulsant medication within 2 weeks prior to consenting to participate in the study, or an injection of botulinum toxin into the affected arm within 4 months prior to consenting to participate in the study, and/or an intention to commence anticonvulsant medication or botulinum toxin injections during the study follow-up period; 10. Severe active psychiatric disorders: Presence of a major active psychiatric disorder likely to interfere with treatment, such as a psychotic disorder or severe personality disorder; 11. Untreated or inadequately treated depression: Untreated or inadequately treated depression, defined as a Beck Depression Inventory-II (BDI-II) score of >=20 at enrolment; 12. Dementia: Diagnosis of dementia; 13. Chronic uncontrolled hypertension or history of cardiovascular disease: chronic uncontrolled hypertension, or a history of severe and uncontrolled cardiovascular disease; 14. Contraindications to magnetic resonance (MR) imaging: for example, incompatibility of body weight with the scanner, or the presence of metallic or electronic implants (pacemakers, defibrillators, spinal cord stimulators, etc.); 15. Severe and poorly controlled medical conditions: Presence of severe and poorly controlled medical conditions which, in the opinion of the Principal Investigator (PI), warrant exclusion as the anticipated risk may exceed that expected in the stroke population; 16. Participation in other clinical trials: At the time of consent to participate in this study, the participant is already enrolled in another trial involving a medical device, biologic or medicinal product that has not been completed within the past 30 days; 17. Pregnancy: Non-pregnant women. Women of childbearing potential must use an acceptable method of contraception. Pregnancy will result in exclusion from or withdrawal from the study; 18. History of hemicraniectomy: History of hemicraniectomy; 19. Small-vessel disease or structural abnormalities: Patients with evident chronic small-vessel ischaemic disease, vertebrobasilar artery disease, and/or any other structural abnormalities of the cerebellum, cerebellar peduncles or brainstem; 20. Other risk-increasing or interfering factors: Patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of all serious adverse events from enrollment through the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional MRI (fMRI);Modified Barthel Index (MBI);EEG;Action Research Arm Test (ARAT) ;Self-Rating Depression Scale (SDS) ;Modified Ashworth Scale (MAS);Timed Up and Go Test (TUG);10-Second Grip and Release Test (HGRT);Self-Rating Anxiety Scale (SAS);Montreal Cognitive Assessment (MoCA);Diffusion Tensor Imaging (DTI);Mini-Mental State Examination (MMSE);Brain fNIRS imaging;Brunnstrom classification;Berg Balance Scale (BBS);Structural MRI;Fugl-Meyer Assessment (FMA) for Upper and Lower Extremity Motor Function; | — |
Countries
China
Contacts
Public ContactTang Zhouping
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed