NEO: Subjects will be implanted with the NEO device.
Study summary
Through brain-computer interface alternative technology, patients can control the external equipment(wheelchairs, robotic arms, the WeChat app and other physical aids)with brain signals to improve the patients quality of life.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged between 18 and 80 years of age;
2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease;
4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment;
5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
Exclusion Criteria:
1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses;
2. Combined with progressive neurological disease;
3. Combined with surgical contraindications identified by surgeons and anesthesiologists;
4. Participating in other clinical trials;
5. Other conditions deemed inappropriate by investigators and medical staff.
Primary outcome measure(s)
Adverse Events — 12 months after implantation Number of Participants With the device-Related Adverse Events
Trial sites (4)
Facility
City
Region
Status
Chinese PLA General Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Xuanwu Hospital,Capital Medical University
Beijing
Beijing Municipality
Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai
Shanghai Municipality
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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