NCT06829212 Research on Wireless Brain Implant System for General Control of External Devices
| NCT ID | NCT06829212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai StairMed Technology Co., Ltd. |
| Condition | Complete or Incomplete Paraplegia/quadriplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 4 participants |
| Start Date | 2025-03 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4 participants in total. It began in 2025-03 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06829212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Complete or Incomplete Paraplegia/quadriplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06829212 currently recruiting?
Yes, NCT06829212 is actively recruiting participants. Contact the research team at kongcen@stairmed.com for enrollment information.
Where is the NCT06829212 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06829212 clinical trial?
NCT06829212 is sponsored by Shanghai StairMed Technology Co., Ltd.. The trial plans to enroll 4 participants.