Amputations, Brainstem Stroke, Quadriplegia, Spinal Cord Injuries (SCI)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEImplant
Implantation of the device and follow-up
Sponsors
Shanghai StairMed Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years; * Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations; * Normal motor cortex function confirmed by neurological assessment; * Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3; * Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months; * Expected lifespan ≥12 months; * Normal cognitive function; * Normal hearing and vision, or corrected vision to normal with standard lenses; * Patients with stable caregivers; * Willing to sign informed consent and able to comply with follow-up requirements.
Exclusion criteria
* Patients with neuropsychiatric disorders or psychological impairments; * Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions; * History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females; * History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries; * Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering; * Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists; * Morbid obesity (BMI \>40); * Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing; * Current participation in other clinical trials; * Other conditions considered unsuitable by investigators or medical staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Within 6 months after implantation | The incidence of adverse events associated with the device or surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WRS Efficacy Assessment- Accuracy | 6 months after the implantation | 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. |
| WRS Efficacy Assessment- Path efficiency | 6 months after the implantation | 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. |
| WRS Efficacy Assessment- Time consumption | 6 months after the implantation | Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance. |
| Neurological Recovery Assessment | 3, 15, 30, 90, 180 days after implantation | 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. |
| Changes in Quality of Life | 3, 15, 30, 90, 180 days after implantation | 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. |
| Changes in Cognitive Performance | 3, 15, 30, 90, 180 days after implantation | 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. |
| Changes in Psychological Status | 3, 15, 30, 90, 180 days after implantation | 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. |
| Changes in Anxiety Status | 3, 15, 30, 90, 180 days after implantation | 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. |
| Changes in Depression Status | 3, 15, 30, 90, 180 days after implantation | 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. |
Countries
China
Contacts
Primary ContactStairmed Clinical team
Outcome results
None listed