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| ID | Type | Description | Link |
|---|---|---|---|
| JJ202503-01 | Other Identifier | IEC of Institution for National Drug Clinical Trials, Tangdu Hospital, Fourth Military Medical University |
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The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation of the WRS64 | Experimental | Implantation of the device and follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant | Device | Implantation of the device and follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The incidence of adverse events associated with the device or surgical procedure | Within 6 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| WRS Efficacy Assessment- Accuracy | Validation of motor function improvement through cursor control performance metrics: the accuracy of of task list (number of correct items/ number of all items), the higher the better. | 6 months after the implantation |
| WRS Efficacy Assessment- Path efficiency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stairmed Clinical team | Contact | +86 021-80510178 | kongcen@stairmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Air Force Medical University | Xi'an | Shaanxi | 710038 | China |
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Validation of motor function improvement is demonstrated through cursor control performance metrics, particularly path efficiency (the ratio of optimal to actual movement path). Higher values indicate better motor control performance. |
| 6 months after the implantation |
| WRS Efficacy Assessment- Time consumption | Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance. | 6 months after the implantation |
| Neurological Recovery Assessment | The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale was used to evaluate overall neurological status. The higher the scale score, the better the overall neurological status. | 3, 15, 30, 90, 180 days after implantation |
| Changes in Quality of Life | Variations in the MOS item short from health survey (SF-36) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). The score values directly reflect health status - higher scores indicate better functional outcomes and superior quality of life. | 3, 15, 30, 90, 180 days after implantation |
| Changes in Cognitive Performance | Variations in Montreal Cognitive Assessment (MoCA) scores scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Elevated scores are associated with improved cognitive function. | 3, 15, 30, 90, 180 days after implantation |
| Changes in Psychological Status | Variations in Patient Health Questionnaire (PHQ-9) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status. | 3, 15, 30, 90, 180 days after implantation |
| Changes in Anxiety Status | Variations in Hamilton Anxiety Rating Scale (HAMA) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status. | 3, 15, 30, 90, 180 days after implantation |
| Changes in Depression Status | Variations in Hamilton Depression Rating Scale (HAMD) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status. | 3, 15, 30, 90, 180 days after implantation |
| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D020526 | Brain Stem Infarctions |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
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