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This prospective, single-arm clinical trial is designed to preliminarily evaluate the safety and efficacy of an implantable wireless brain-computer interface (BCI) system (manufactured by Shanghai StairMed Technology Co., Ltd.) in enabling subjects with speech disorders to achieve brain-controlled interaction and communication. Eligible subjects will undergo surgical implantation of the device and receive brain-control training. All participants will be followed for an expected period of 12 months. During the follow-up, adverse events, serious adverse events, and device deficiencies will be recorded, and efficacy data on brain-controlled interaction and communication will be collected. The goal is to conduct an initial assessment of the safety and effectiveness of the investigational device in achieving brain-controlled effects in the target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation of the WRS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WRS | Device | WRS is a minimally invasive, wireless brain-machine interface system. Subjects with speech disorders undergo implantation of WRS, receive brain-control training, and are followed up. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device-Related Adverse Events | Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period. | From implantation to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Adverse Events | From implantation to Month 12 | |
| Incidence of Device Deficiencies | From implantation to Month 12 | |
| Number of Reliable Recording Channels at Each Evaluation Time Point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical team Stairmed | Contact | +86 021-80510178 | yumiao@stairmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| At 3, 6, 9, and 12 months post-implantation |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |