Wireless brain implant for controlling devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.