Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Launched by NEURACLE MEDICAL TECHNOLOGY(SHANGHAI) CO.,LTD. · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new system that helps people with motor disabilities, specifically those with tetraplegia, which is a condition that affects movement in all four limbs. The system uses a brain-computer interface, allowing participants to control devices like wheelchairs and robotic arms just by thinking about it. The goal is to see if this technology can improve the quality of life for individuals by making it easier for them to interact with their environment.

To be eligible for this trial, participants need to be between 18 and 80 years old and have experienced complete or partial paralysis due to conditions like spinal cord injuries or certain neurological disorders for at least a year. They should also have stable health for the past six months and be able to understand and follow instructions. If you join the study, you can expect to work with researchers who will monitor your progress and help you learn to use the new system. It's important to know that individuals with certain visual impairments or other serious health issues may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 and 80 years of age;
• • 2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
• • 3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
• • 4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
• • 5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
• Exclusion Criteria:
• • 1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
• • 2. Combined with progressive neurological disease；
• • 3. Combined with surgical contraindications identified by surgeons and anesthesiologists;
• • 4. Participating in other clinical trials;
• • 5. Other conditions deemed inappropriate by investigators and medical staff.