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Study on the safety and effectiveness of stent system brain computer interface implantation for the treatment of acute disabling ischemic stroke

Study on the safety and effectiveness of stent system brain computer interface implantation for the treatment of acute disabling ischemic stroke

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096477
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-01-27
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Intervention group:Thrombolysis stent brain computer interface implantation therapy

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age: >= 18 years old; 2. Suitable for neurointerventional surgery; 3. Having normal venous sinus anatomy, bilateral jugular veins are unobstructed (size suitable for the device), and both smooth lateral transverse sinus; 4. Specific spinal cord level muscle strength rating still exists after 6 months of treatment for acute ischemic stroke MRC should be at least: C5<=4/5 grade, C6<=2/5 grade, C7-T1<=1/5 grade; 5. No eye movement disorders that may hinder the use of eye tracking software, and possess visual acuity, the level will not affect the viewing of the screen and visual content; 6. Obtain informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are serious important organ dysfunction, infectious diseases, coagulation disorders related diseases; 2. There is immune suppression; 3. Intolerance to anesthesia; 4. Allergic to contrast agents; 5. Allergic to platinum iridium alloy and nickel; 6. History of pulmonary embolism or recent deep vein thrombosis; 7. Existence of mental illness or psychological disorders; 8. Any bleeding disorders or resistance to aspirin and/or clopidogrel; 9. There are actively implanted stimulation devices (such as pacemakers, deep brain stimulators, spinal cord stimulators); 10. No long-term caregivers; 11. The life expectancy of any disease in the late stage is less than 12 months.

Design outcomes

Primary

MeasureTime frame
Serious adverse events related to the device;Causing death within 12 months after implantation;Causing an increase in permanent disability within 12 months after implantation;

Secondary

MeasureTime frame
Target vessel occlusion, thrombosis, and device migration events occur;Five level and five dimensional health scale Score;Hospital Anxiety and Depression Scale Score;Visual Analog Scale Score;

Countries

China

Contacts

Public ContactYang Qingwu

The Second Affiliated Hospital of the Army Medical University

yangqwmlys@163.com+86 136 5763 8868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026