Clinical trial NCT06944834: A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Official title: A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quadriplegia
Amputations
Spinal Cord Injuries (SCI)
Brainstem Stroke
Lead sponsor: Shanghai StairMed Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Adverse events
timeFrame: Within 6 months after implantation
Secondary outcomes:
measure: WRS Efficacy Assessment- Accuracy
timeFrame: 6 months after the implantation
measure: WRS Efficacy Assessment- Path efficiency
timeFrame: 6 months after the implantation
measure: WRS Efficacy Assessment- Time consumption
timeFrame: 6 months after the implantation
measure: Neurological Recovery Assessment
timeFrame: 3, 15, 30, 90, 180 days after implantation
measure: Changes in Quality of Life
timeFrame: 3, 15, 30, 90, 180 days after implantation
measure: Changes in Cognitive Performance
timeFrame: 3, 15, 30, 90, 180 days after implantation
measure: Changes in Psychological Status
timeFrame: 3, 15, 30, 90, 180 days after implantation
measure: Changes in Anxiety Status
timeFrame: 3, 15, 30, 90, 180 days after implantation
measure: Changes in Depression Status
timeFrame: 3, 15, 30, 90, 180 days after implantation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Medical University
state: Shaanxi
Study officials:
References: