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

Launched by SHANGHAI STAIRMED TECHNOLOGY CO., LTD. · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device called a wireless brain-computer interface. This technology aims to help people with paralysis (due to conditions like spinal cord injuries or strokes) or those who have lost both arms to control devices like wheelchairs or robotic arms using their brain signals. The goal is to see if this device can improve their ability to move and enhance their overall quality of life.

To participate in this study, you need to be an adult between 18 and 65 years old and have certain types of paralysis or bilateral arm amputations. You should also have a stable medical condition and be able to understand and comply with the study requirements. If you join, you will be monitored closely to ensure the device is safe and effective for helping you regain some control over your movements. This study is not yet recruiting, so there’s no immediate commitment, but it could offer new hope for better mobility and independence for those who qualify.

Gender

ALL

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.