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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis; Spinal Cord Injury; Brainstem Stroke; Bilateral Upper Limb Amputation; Complete or Incomplete Paraplegia/quadriplegia
• Intervention / Treatment: Device: WRS

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stairmed Clinical team; Phone Number: 021-80510178; Email: kongcen@stairmed.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital affiliated to Fudan University
      • Contact: Junfeng Lu, Dr.; Phone Number: 021-54601999; Email: sherley_76@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation; Implantation of the WRS64	Device: WRS; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device-Related Adverse Events (AE)	Through study completion, an average of 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events		Through study completion, an average of 7 months
Serious Adverse Event		Through study completion, an average of 7 months
BPS	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.	At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Usage Time (hours/month)	The amount of time the subject uses the experimental device each month.	At an average of 5 to 7 months after implantation, during the follow-up phases.
Accuracy	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.	At an average of 5 to 7 months after implantation, during the follow-up phases.
Psychological State	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).	At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Caregiver Burden	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).	At an average of 4 to 7 months after implantation, both before and during the follow-up phases.

Collaborators and Investigators

• Sponsor: Shanghai StairMed Technology Co., Ltd.
• Collaborators: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Metabolic Diseases; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Neurodegenerative Diseases; Trauma, Nervous System; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Ischemia; Stroke; Paralysis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Quadriplegia; Paraplegia; Brain Stem Infarctions
• Other Study ID Numbers: PI2302-CL-01-001; 2024-1325 (Other Identifier: Huashan Hospital Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No