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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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).

Первичные конечные точки

• Device-Related Adverse Events (AE) [Срок оценки: Through study completion, an average of 7 months]

Вторичные конечные точки (7)

• Adverse Events [Срок оценки: Through study completion, an average of 7 months]
• Serious Adverse Event [Срок оценки: Through study completion, an average of 7 months]
• BPS [Срок оценки: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.]
• Usage Time (hours/month) [Срок оценки: At an average of 5 to 7 months after implantation, during the follow-up phases.]
• Accuracy [Срок оценки: At an average of 5 to 7 months after implantation, during the follow-up phases.]
• Psychological State [Срок оценки: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.]
• Caregiver Burden [Срок оценки: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT06829212 · PI2302-CL-01-001 · 2024-1325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗