A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation (STAIR)

Shanghai StairMed Technology Co., Ltd.

Status: Not yet enrolling

Conditions: Spinal Cord Injuries (SCI); Brainstem Stroke; Amputations; Quadriplegia

Treatments: Device: Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06944834

PI2302-CL-01-002

JJ202503-01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Implantation of the WRS64

Experimental group

Description:

Implantation of the device and follow-up

Treatment:

Device: Implant