Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
- Conditions
- Tetraplegia
- Interventions
- Device: NEO
- Registration Number
- NCT05920174
- Lead Sponsor
- Neuracle Medical Technology(Shanghai) Co.,Ltd.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single NEO 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.
- Primary Outcome Measures
Name Time Method Adverse Events 12 months after implantation Number of Participants With the device-Related Adverse Events
- Secondary Outcome Measures
Name Time Method BCI performance by bit rate 3, 6, 12 months after implantation 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 3, 6, 12 months after implantation Hours use of the implantable neural acquisitor \& stimulator (NEO) per month
BCI performance classification accuracy 3, 6, 12 months after implantation 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)
Patient/caregiver satisfaction 3, 6, 12 months after implantation 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.
Trial Locations
- Locations (4)
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China