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

Last updated: March 10, 2025
Sponsor: Shanghai StairMed Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Limb Spasticity

Spinal Cord Disorders

Treatment

WRS

Clinical Study ID

NCT06829212
PI2302-CL-01-001
2024-1325
  • Ages 18-80
  • All Genders

Study 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

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 bilateralupper limb amputation.

  • Diagnosis stable for at least 6 months before screening, with the condition presentfor at least 1 year.

  • Willing to follow the study protocol and attend all visits, with or withoutcaregiver assistance.

  • Informed consent signed by participant and/or caregiver, with full understanding ofthe trial's purpose.

Exclusion

Exclusion Criteria:

  • Previous implantation of metal objects or devices (except dental implants ornon-impacting implants).

  • Long-term use of anticoagulants/antiplatelets with insufficient cessation, orabnormal 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.

Study Design

Total Participants: 4
Treatment Group(s): 1
Primary Treatment: WRS
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
February 28, 2027

Study Description

The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience.

The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.

Connect with a study center

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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