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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
Adverse events — Within 6 months after implantation The incidence of adverse events associated with the device or surgical procedure
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Air Force Medical University
Xi'an
Shaanxi
More Shanghai StairMed Technology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.