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Clinical Trials in China / NCT06829212
Recruiting Not applicable

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

NCT06829212 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai StairMed Technology Co., Ltd
Phase
Not applicable
Started
2025-03
Last updated
2025-03-13

Condition(s) studied

Complete or Incomplete Paraplegia/quadriplegiaSpinal Cord InjuryBrainstem StrokeAmyotrophic Lateral SclerosisBilateral Upper Limb Amputation

Investigational drug(s) / intervention(s)

WRS

WRS: WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).

Study summary

The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.

WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Device-Related Adverse Events (AE) — Through study completion, an average of 7 months

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality Recruiting

More Shanghai StairMed Technology Co., Ltd. trials in China

Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation Recruiting
Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study Recruiting
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation Starting soon

Other trials for the same condition

Explore Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China Enrolling by invitation
Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS) Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene Mutation Recruiting
An IIT Clinical Study to Evaluate the Safety and Efficacy of a Single Intrathecal Injection of RJK002 in Patients With ALS Active, not recruiting
Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06829212 on ClinicalTrials.gov ↗ ← All trials in China