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.
Aged between 18 and 80 years of age;
Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
Combined with progressive neurological disease；
Combined with surgical contraindications identified by surgeons and anesthesiologists;
Participating in other clinical trials;
Single group
NEO
DeviceSubjects will be implanted with the NEO device.
Adverse Events
Number of Participants With the device-Related Adverse Events
BCI performance classification accuracy
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by classification accuracy (percentage of patient correct commands to overall number of detected commands)
BCI performance by bit rate
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by bit rate (number of commands per minute).
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Hours use of the implantable neural acquisitor \& stimulator (NEO) per month
Patient/caregiver satisfaction
The evaluation of patient and caregiver satisfaction will be carried out using a "satisfaction questionnaire" designed by the researcher (rated from Level 1 to 5) on their feelings (patient/caregiver) of use.
Click on the lead sponsor to view all of their trials.
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Lead sponsor
Xuanwu Hospital, Beijing
Collaborator
Beijing Tiantan Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Huashan Hospital
Collaborator
