Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Conditions
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Tetraplegia

Intervention / Treatment
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* Device: NEO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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； The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial. Exclusion Criteria: 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; Other conditions deemed inappropriate by investigators and medical staff.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: an implantable neural acquisitor & stimulator system
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single<br>Patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders). Implantation of NEO device. | Device: NEO<br>* Subjects will be implanted with the NEO device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of Participants With the device-Related Adverse Events | 12 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 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 | 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. | 3, 6, 12 months after implantation |