Amyotrophic Lateral Sclerosis, Bilateral Upper Limb Amputation, Brainstem Stroke, Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEWRS
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).
Sponsors
Huashan Hospital
Shanghai StairMed Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-80 years (inclusive), any gender. * Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation. * Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year. * Willing to follow the study protocol and attend all visits, with or without caregiver assistance. * Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
Exclusion criteria
* Previous implantation of metal objects or devices (except dental implants or non-impacting implants). * Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results. * Unable to tolerate anesthesia or surgery. * Severe neurological disorders or brain injury leading to significant dysfunction. * Scalp conditions that may impair wound healing. * Acute or severe infections. * Cognitive impairment or psychiatric disorders. * Severe dysfunction of vital organs, malignancies, or autoimmune diseases. * Life expectancy under 1 year. * Drug or alcohol abuse. * Pregnant, breastfeeding, or planning pregnancy during the study. * Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device-Related Adverse Events (AE) | Through study completion, an average of 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Event | Through study completion, an average of 7 months | — |
| BPS | At an average of 4 to 7 months after implantation, both before and during the follow-up phases. | 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. |
| Usage Time (hours/month) | At an average of 5 to 7 months after implantation, during the follow-up phases. | The amount of time the subject uses the experimental device each month. |
| Adverse Events | Through study completion, an average of 7 months | — |
| Psychological State | At an average of 4 to 7 months after implantation, both before and during the follow-up phases. | 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). |
| Caregiver Burden | At an average of 4 to 7 months after implantation, both before and during the follow-up phases. | 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). |
| Accuracy | At an average of 5 to 7 months after implantation, during the follow-up phases. | 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. |
Countries
China
Contacts
Primary ContactStairmed Clinical team
Outcome results
None listed