Wireless brain implant for controlling 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
NA · Shanghai StairMed Technology Co., Ltd. · NCT06829212
This study is testing a new wireless brain implant that helps paralyzed and amputee patients control devices just by thinking, to see if it can improve their daily lives.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai StairMed Technology Co., Ltd. (industry) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06829212 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a minimally invasive wireless brain-machine interface system designed to enable paralyzed and amputee patients to control external devices through neural signals. The system integrates a high-throughput, ultra-flexible neural electrode that is fully embedded within the body, leaving no visible external traces. Participants will be able to operate devices such as cursors and assistive technologies solely through thought, enhancing their quality of life and daily convenience. The study aims to provide significant improvements in communication, skill acquisition, and entertainment opportunities for participants.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with complete or incomplete paraplegia, quadriplegia, spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or bilateral upper limb amputation.
Not a fit: Patients with severe neurological disorders or brain injuries leading to significant dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly enhance the independence and quality of life for patients with severe mobility impairments.
How similar studies have performed: Other studies have shown promise in using brain-machine interfaces for similar applications, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Stairmed Clinical team
- Email: kongcen@stairmed.com
- Phone: 021-80510178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis, Bilateral Upper Limb Amputation