A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implant.
- Who it may be relevant to
- Registry conditions: Quadriplegia, Amputations, Spinal Cord Injuries (SCI), Brainstem Stroke. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Implant
Implantation of the device and follow-up
Primary outcome measures
- Adverse events [Time frame: Within 6 months after implantation]
Secondary outcome measures (9)
- WRS Efficacy Assessment- Accuracy [Time frame: 6 months after the implantation]
- WRS Efficacy Assessment- Path efficiency [Time frame: 6 months after the implantation]
- WRS Efficacy Assessment- Time consumption [Time frame: 6 months after the implantation]
- Neurological Recovery Assessment [Time frame: 3, 15, 30, 90, 180 days after implantation]
- Changes in Quality of Life [Time frame: 3, 15, 30, 90, 180 days after implantation]
- Changes in Cognitive Performance [Time frame: 3, 15, 30, 90, 180 days after implantation]
- Changes in Psychological Status [Time frame: 3, 15, 30, 90, 180 days after implantation]
- Changes in Anxiety Status [Time frame: 3, 15, 30, 90, 180 days after implantation]
- Changes in Depression Status [Time frame: 3, 15, 30, 90, 180 days after implantation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
China · 1 center
- The Second Affiliated Hospital of Air Force Medical University — Xi'an
Identifiers
NCT: NCT06944834 · PI2302-CL-01-002 · JJ202503-01