Endovascular Brain-Computer Interface for Upper-Limb Paralysis

Ki vehet részt

• Clinical diagnosis of one of the following movement disorders:; post-stroke hemiplegia, paraplegia due to spinal cord injury, or ALS (limb-onset spinal type or progressive muscular atrophy type)
• Rehabilitation group only: disease duration within 6 months, residual upper-limb motor potential (muscle strength grade >=1), with activatable target motor cortex confirmed by fMRI or magnetoencephalography (MEG)
• Assistance group only: ALS diagnosed by revised El Escorial criteria or severe paraplegia (ASIA grade A/B), with no realistic prospect of recovering voluntary movement
• Age 20 to 75 years
• Life expectancy greater than 12 months
• Normal venous sinus anatomy with two patent jugular veins large enough to accommodate the device and patent bilateral transverse sinuses, confirmed by MRV or CTV within the last 3 months, or willingness to undergo MRV/CTV assessment if venous anatomy is unknown
• Evidence of activation in the target motor cortex near the superior sagittal sinus during limb movement, confirmed by fMRI or MEG
• No significant visual impairment
• Written informed consent signed by the participant or legal guardian
• Clear expressed preference for either short-term sensor removal (approximately 1 month after implantation) or long-term retention until the end of follow-up, documented in a signed preference confirmation form
• Vascular lesions (stenosis, occlusion, aneurysm) requiring further intervention discovered during angiography do not affect eligibility; such treatment may proceed 24 hours after angiography

Ki nem vehet részt

• In the investigator's opinion, unrealistic expectations regarding the benefits, risks, and limitations of implantation or surgery
• Dementia or cognitive impairment sufficient to affect capacity to provide informed consent or to comply with the protocol (e.g., MMSE <24, ECAS, or other assessment), or epileptiform discharges on EEG
• Presence of an active implanted stimulation device (e.g., cardiac pacemaker, deep brain stimulator, spinal cord stimulator)
• Known allergy to contrast agent
• Any bleeding disorder (to be tested for if clinical status is unknown), resistance to aspirin and/or clopidogrel, or any contraindication to antithrombotic therapy
• Allergy to any material contained in the implanted device
• History of deep vein thrombosis or current hormone replacement therapy
• Any serious illness that, in the investigators' opinion, could severely limit the ability to participate in the study
• History of any of the following: cerebral venous sinus thrombosis, venous hypertension, hydrocephalus after cranioplasty, other severe cardiopulmonary disease, or cancer
• Contraindication to angiography, including chronic kidney injury (eGFR <60 mL/min)
• Unwillingness to comply with all study procedures
• Contraindication to MRI, or microbleeds on SWI-MRI
• Pregnancy, pregnancy planned within 1 year, or breastfeeding
• Judged unsuitable for general anesthesia by an anesthesiologist or respiratory physician
• Venous anatomy unsuitable for superior sagittal sinus implantation as assessed by an experienced neurointerventionalist (e.g., isolated dominant superior anastomotic/Trolard vein or other unfavorable venous variants)
• Inability to comply with follow-up, or absence of a family member or caregiver able to attend the consent process and support study visits