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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-1325 | Other Identifier | Huashan Hospital Institutional Review Board |
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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
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The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.
WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.
The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience.
The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation | Experimental | Implantation of the WRS64 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WRS | Device | WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01). |
| Measure | Description | Time Frame |
|---|---|---|
| Device-Related Adverse Events (AE) | Through study completion, an average of 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Through study completion, an average of 7 months | |
| Serious Adverse Event | Through study completion, an average of 7 months | |
| BPS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stairmed Clinical team | Contact | 021-80510178 | kongcen@stairmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D020526 | Brain Stem Infarctions |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Bits per second, determined by the net number of correct targets selected per minute (NTPM) during task participation by the subject, and the grid size. |
| At an average of 4 to 7 months after implantation, both before and during the follow-up phases. |
| Usage Time (hours/month) | The amount of time the subject uses the experimental device each month. | At an average of 5 to 7 months after implantation, during the follow-up phases. |
| Accuracy | The percentage of correctly completed commands from the total commands in the predefined task list, which are independently completed by the subject within a specified time. | At an average of 5 to 7 months after implantation, during the follow-up phases. |
| Psychological State | The subject and/or their caregiver will complete the checklist to assess psychological states and other relevant indicators (each question is graded from 1 to 5, with lower values being better). | At an average of 4 to 7 months after implantation, both before and during the follow-up phases. |
| Caregiver Burden | The subject's caregiver will complete the checklist to assess caregiver burden and other related indicators (each question is scored from 0 to 4, with lower scores being better). | At an average of 4 to 7 months after implantation, both before and during the follow-up phases. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |