Cerebral infarction
Conditions
Interventions
Test group:Receiving intravenous interventional brain machine type A sensor therapy
Control group:Routine rehabilitation
Sponsors
Fujian Sanbo Funeng brain Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Clinical diagnosis of limb motor dysfunction after treatment of cerebral infarction. 2.Within 6 months of disease duration. 3. 45-75 years of age. 4.Have a life expectancy extension greater than 12 months. 5.Have normal venous sinus anatomy with two patent jugular veins (large enough to accommodate the device), and bilateral patent transverse sinuses, as confirmed by MR venography (MRV) or CT venography (CTV) within the last 3 months or, if the vascular anatomy is unknown, those who are willing to undergo an MRV or CTV evaluation to assess the vascular suitability for treatment. 6. Who have evidence of functional activation in targeted motor cortex areas near the superior sagittal sinus confirmed by fMRI. 7. Who have no significant visual impairment. 8. Who sign an informed consent form. 9. If the angiographic procedure reveals that the patient has a combined arterial stenosis, occlusion, aneurysm, or other lesion that requires further intervention, the patient may be treated 24 hours after angiography, and such cases will not be affected by enrolment in intravenous interventional Brain Machine Type A sensor therapy.
Exclusion criteria
Exclusion criteria: 1. Is unwilling to comply with all procedures associated with the study. 2. Holds unrealistic expectations about the possible benefits, risks, and limitations of the implantation or surgical procedure based on the physician's opinion. 3. Have dementia or cognitive dysfunction sufficient to interfere with the ability to provide informed consent or which may interfere with the ability to comply with protocol investigation requirements (e.g., MMSE <24, ECAS or other judgement by the investigator) or examinations suggestive of epileptiform discharges 4. Contraindications to magnetic resonance imaging (MRI) examination. 5. Implanted with an active stimulation device (e.g., pacemaker, deep brain stimulator, spinal cord stimulator). 6. Pregnant or planning to become pregnant within 1 year, breastfeeding women. 7. Who, in the opinion of a specialist anaesthetist or respiratory surgeon, are not suitable for general anaesthetic surgery. 8. Who, in the opinion of an experienced neurointerventionalist evaluating the MRV, are not suitable for superior sagittal sinus implantation (e.g., isolated dominant, superiorly branched anastomotic vein (Trolard vein)). 9. Have contraindications to angiographic imaging, including chronic kidney injury (CKI - eGFR < 60mls/min). 10. Have a known allergy to contrast media. 11. The presence of any haemorrhagic disease (if the clinical condition is unknown), or resistance to aspirin and/or clopidogrel, or any contraindication to antithrombotic therapy. 12. Hypersensitivity to any material contained in the implanted device. 13. Have a history of deep vein thrombosis (DVT) or be on hormone replacement therapy. 14. Any serious medical condition that, in the opinion of the study investigator, is likely to seriously impair the ability to participate in the study. 15. Persons who are unable to co-operate with follow-up visits and who do not have family members/carers who can be present during the consent process and support all study visits. 16. Persons with a history of any of the following: venous sinus thrombosis, venous hypertension, hydrocephalus or haemorrhagic disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalogram (EEG); | — |
Countries
China
Contacts
Public ContactZhixiong Lin
Fujian Sanbo Fukuneng Brain Hospital
Outcome results
None listed