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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| First Affiliated Hospital of Fujian Medical University |
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To evaluate the safety and efficacy of a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO in patients with tetraplegia and to provide a basis for product registration.
Through brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEO | Device | a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO |
|
| Measure | Description | Time Frame |
|---|---|---|
| BCI-assisted ARAT grasp response rate | At 3 months post-operation, the investigator will assess and record the subject's ARAT (Action Research Arm Test) score under BCI-assisted conditions, then compare it with the subject's baseline unassisted ARAT grasp score. The response rate will be calculated as the percentage of responders relative to the total number of participants. | 3 months post-operation |
| Adverse Events | Immediately post-implantation, and at 3-, and 6-months post-operation. |
| Measure | Description | Time Frame |
|---|---|---|
| ISNCSCI Score of the Participant | The investigator completes the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) form. | Baseline, and at 3-, and 6-months post-operation. |
| ARAT Score for BCI-Assisted Grasping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Liu | Contact | +021-58086056 | liutao@neuracle.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital,Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| OTHER |
| Beijing Tiantan Hospital | OTHER |
| Henan Provincial People's Hospital | OTHER |
| West China Hospital | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
| The General Hospital of Eastern Theater Command | OTHER |
| Peking University Third Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Tongji Hospital | OTHER |
a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
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The investigator completes the ARAT (Action Research Arm Test) scoring form.
| 2-, and 6-months post-operation |
| ARAT Score | Investigators will complete the ARAT (Action Research Arm Test) Assessment Form. | Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off). |
| Investigator's Overall Device Performance Evaluation | Investigators will complete the Investigator's Overall Device Performance Evaluation Form. | Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation. |
| Subject's Overall Device Performance Evaluation | Subjects will complete the Subject Device Performance Evaluation Questionnaire. | 2-, 3-, and 6-months post-operation. |
| Device Impedance | Record the impedance of each channel; impedance is considered normal if it does not exceed 20 kΩ. | 1, 2-, 3-, and 6-months post-operation. |
| Average Monthly Device Usage Time | Calculate the total device usage time per month for each participant. | 2-, 3-, and 6-months post-operation. |
| Participant Quality of Life Score | Assessment Method: Participants complete the "Quality of Life Questionnaire" | Baseline, and at 2-, 3-, and 6-months post-operation. |
| Subject Satisfaction Rating | Participants evaluate the device's connectivity, operational performance, structural design, and functional design at each follow-up visit. | 2-, 3-, and 6-months post-operation. |
| Investigator Satisfaction with Device Operation | At the 1, 2, 3 and 6-month follow-up visits, investigators evaluate the device's connectivity and stability, as well as its electromagnetic compatibility. | 1-, 2-, 3-, and 6-months post-operation. |
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
|
| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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