Research on Wireless Brain Implant System for General Control of External Devices

Launched by SHANGHAI STAIRMED TECHNOLOGY CO., LTD. · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new technology called the Wireless Brain Implant System (WRS) designed to help people with conditions like complete or incomplete paralysis, spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis (ALS), or those who have lost both arms due to amputation. The goal of the study is to see if this small, safe, and invisible brain-machine interface can allow these individuals to control devices such as a computer cursor or other assistive tools just by thinking about it.

To participate in the trial, you need to be between 18 and 80 years old and have a stable condition that has caused paralysis or limb loss for at least a year. Participants should be willing to attend all study visits and understand the trial's purpose. If you qualify and choose to join, you can expect to undergo a minimally invasive procedure to have the implant placed in your body, which will not leave any visible marks. The trial is currently looking for participants, and it's a chance to contribute to research that could significantly improve the lives of people with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-80 years (inclusive), any gender.
• • Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
• • Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
• • Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
• • Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
• Exclusion Criteria:
• • Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
• • Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
• • Unable to tolerate anesthesia or surgery.
• • Severe neurological disorders or brain injury leading to significant dysfunction.
• • Scalp conditions that may impair wound healing.
• • Acute or severe infections.
• • Cognitive impairment or psychiatric disorders.
• • Severe dysfunction of vital organs, malignancies, or autoimmune diseases.
• • Life expectancy under 1 year.
• • Drug or alcohol abuse.
• • Pregnant, breastfeeding, or planning pregnancy during the study.
• • Other conditions deemed unsuitable by the investigator.