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.
To evaluate the safety and efficacy of an implantable neural acquisitor \& stimulator system in patients with motor disability(Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders). 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
Subjects will be implanted with the NEO device.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGXuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Adverse Events
Number of Participants With the device-Related Adverse Events
Time frame: 12 months after implantation
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)
Time frame: 3, 6, 12 months after implantation
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).
Time frame: 3, 6, 12 months after implantation
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Hours use of the implantable neural acquisitor \& stimulator (NEO) per month
Time frame: 3, 6, 12 months after implantation
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.
Time frame: 3, 6, 12 months after implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING