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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Huashan Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEO | Device | Subjects will be implanted with the NEO device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Participants With the device-Related Adverse Events | 12 months after implantation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Liu, Master | Contact | 021-58086056 | liutao@neuracle.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100039 | China |
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| OTHER |
an implantable neural acquisitor & stimulator system
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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 |
| Xuanwu Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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