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NCT Number: NCT06829212

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

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.

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Key information

Conditions

Complete or Incomplete Paraplegia/quadriplegia Amyotrophic Lateral Sclerosis Bilateral Upper Limb Amputation Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Brainstem Stroke Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Metabolic Diseases Motor Neuron Disease Necrosis Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Stroke TDP-43 Proteinopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Junfeng Lu, Dr.

CONTACT

[email protected]

021-54601999

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WRS

Device

WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).

Primary outcomes

  1. Device-Related Adverse Events (AE)

    Time frame: Through study completion, an average of 7 months

Secondary outcomes

  1. Adverse Events

    Time frame: Through study completion, an average of 7 months

  2. Serious Adverse Event

    Time frame: Through study completion, an average of 7 months

  3. BPS

    Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.

    Bits per second, determined by the net number of correct targets selected per minute (NTPM) during task participation by the subject, and the grid size.

  4. Usage Time (hours/month)

    Time frame: At an average of 5 to 7 months after implantation, during the follow-up phases.

    The amount of time the subject uses the experimental device each month.

  5. Accuracy

    Time frame: At an average of 5 to 7 months after implantation, during the follow-up phases.

    The percentage of correctly completed commands from the total commands in the predefined task list, which are independently completed by the subject within a specified time.

  6. Psychological State

    Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.

    The subject and/or their caregiver will complete the checklist to assess psychological states and other relevant indicators (each question is graded from 1 to 5, with lower values being better).

  7. Caregiver Burden

    Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.

    The subject's caregiver will complete the checklist to assess caregiver burden and other related indicators (each question is scored from 0 to 4, with lower scores being better).

Study contacts

Contact information is provided by the study sponsor or research team.

Stairmed Clinical team

CONTACT

[email protected]

021-80510178

Sponsors and collaborators

Lead sponsor

Shanghai StairMed Technology Co., Ltd.

Industry

Collaborators

  • Huashan Hospital

Registry information

Official study title

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

Acronym: RISE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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