NCT06829212Recruiting
Research on Wireless Brain Implant System for General Control of External Devices
A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed/Amputee Patients
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- First submitted
- 5 Feb 2025
- Start date
- Mar 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.
- Diseases
- ALS (motor neurone disease), Stroke
- NCT number
- NCT06829212
What you commit to
- Study type: Interventional
- Planned participants: 4
- From Mar 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
- Unable to tolerate anesthesia or surgery.
- Drug or alcohol abuse.
Other illness
- 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.
- Other conditions deemed unsuitable by the investigator.
Other
- Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
- Life expectancy under 1 year.
- Pregnant, breastfeeding, or planning pregnancy during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.