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

N/ANot Yet RecruitingNCT06944834

Shanghai StairMed Technology Co., Ltd.5 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Quadriplegia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Adverse events

The incidence of adverse events associated with the device or surgical procedure

Time frame: Within 6 months after implantation

Secondary Outcomes

WRS Efficacy Assessment- Accuracy

Validation of motor function improvement through cursor control performance metrics: the accuracy of of task list (number of correct items/ number of all items), the higher the better.

Time frame: 6 months after the implantation

WRS Efficacy Assessment- Path efficiency

Validation of motor function improvement is demonstrated through cursor control performance metrics, particularly path efficiency (the ratio of optimal to actual movement path). Higher values indicate better motor control performance.

Time frame: 6 months after the implantation

WRS Efficacy Assessment- Time consumption

Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance.

Time frame: 6 months after the implantation

Neurological Recovery Assessment

The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale was used to evaluate overall neurological status. The higher the scale score, the better the overall neurological status.