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

Recruiting now · Not applicable

Conditions studied: Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis, Bilateral Upper Limb Amputation

In brief

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.

Key facts

Study ID

NCT06829212

Run by

Shanghai StairMed Technology Co., Ltd.

People needed

4

Starts

2025-03-01

Expected to finish

2027-02-01

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.