Tests a wireless brain implant to help paralyzed people control devices
Tests a wireless brain implant letting paralysis or amputation patients control devices.
Plain-language title generated from the registry record
Registry title: A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Key facts
- Where
- Xi’an, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-65 with paralysis of the arms and legs (from spinal cord injury, brainstem stroke, ALS or another motor neuron disease) or with both upper limbs amputated. It tests a wireless brain implant that lets them control devices with brain signals.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Complete or incomplete quadriplegia, or amputation of both upper limbs. Arm muscle strength of Grade 3 or lower. Disease stable for at least 6 months. Standard treatment received and diagnosis met for at least 12 months before screening. Expected lifespan of at least 12 months.
- Earlier treatment
- Standardized treatment for at least 12 months before screening.
- Biomarker or test result
- Normal motor cortex function confirmed by a neurological assessment.
Main reasons for not taking part
- Neuropsychiatric disorders or psychological impairments
- Brain MRI showing bleeding, tumors or structural abnormalities
- Severe systemic disease, poorly controlled diabetes or pregnancy
- Infectious disease such as syphilis or HIV, severe traumatic brain injury or major surgery
- Metal implants or devices such as pacemakers or cochlear implants, or BMI above 40
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06944834, who can take part
Where in China
- The Second Affiliated Hospital of Air Force Medical UniversityXi’an, ChinaContact: Ruili Zhang, Ph.DNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai StairMed Technology Co., Ltd.
- Trial code
- NCT06944834
- Record updated
- 25 April 2025
- Original 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.Read full original descriptionShow less
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
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.
Inclusion: 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: 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; 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; Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing; Other conditions considered unsuitable by investigators or medical staff; Morbid obesity (BMI >40); Current participation in other clinical trials.