Clinical trial NCT06829212: Research on Wireless Brain Implant System for General Control of External Devices
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complete or Incomplete Paraplegia/quadriplegia
Spinal Cord Injury
Brainstem Stroke
Amyotrophic Lateral Sclerosis
Bilateral Upper Limb Amputation
Lead sponsor: Shanghai StairMed Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Huashan Hospital
First posted: 2025-02-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Device-Related Adverse Events (AE)
timeFrame: Through study completion, an average of 7 months
Secondary outcomes:
measure: Adverse Events
timeFrame: Through study completion, an average of 7 months
measure: Serious Adverse Event
timeFrame: Through study completion, an average of 7 months
measure: BPS
timeFrame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
measure: Usage Time (hours/month)
timeFrame: At an average of 5 to 7 months after implantation, during the follow-up phases.
measure: Accuracy
timeFrame: At an average of 5 to 7 months after implantation, during the follow-up phases.
measure: Psychological State
timeFrame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
measure: Caregiver Burden
timeFrame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: