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Набор скоро начнётся NCT06944834

A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation

Без фазы С лечением Quadriplegia Amputations Spinal Cord Injuries (SCI) Brainstem Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Implant.
Кому может быть актуально
Состояния в реестре: Quadriplegia, Amputations, Spinal Cord Injuries (SCI), Brainstem Stroke. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.

Подробное описание

The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.

Вмешательства

  • Устройство Implant
    Implantation of the device and follow-up

Первичные конечные точки

  • Adverse events [Срок оценки: Within 6 months after implantation]
Вторичные конечные точки (9)
  • WRS Efficacy Assessment- Accuracy [Срок оценки: 6 months after the implantation]
  • WRS Efficacy Assessment- Path efficiency [Срок оценки: 6 months after the implantation]
  • WRS Efficacy Assessment- Time consumption [Срок оценки: 6 months after the implantation]
  • Neurological Recovery Assessment [Срок оценки: 3, 15, 30, 90, 180 days after implantation]
  • Changes in Quality of Life [Срок оценки: 3, 15, 30, 90, 180 days after implantation]
  • Changes in Cognitive Performance [Срок оценки: 3, 15, 30, 90, 180 days after implantation]
  • Changes in Psychological Status [Срок оценки: 3, 15, 30, 90, 180 days after implantation]
  • Changes in Anxiety Status [Срок оценки: 3, 15, 30, 90, 180 days after implantation]
  • Changes in Depression Status [Срок оценки: 3, 15, 30, 90, 180 days after implantation]

Критерии участия

Критерии включения

  • Adults aged 18-65 years;
  • Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
  • Normal motor cortex function confirmed by neurological assessment;
  • Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
  • Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;
  • Expected lifespan ≥12 months;
  • Normal cognitive function;
  • Normal hearing and vision, or corrected vision to normal with standard lenses;
  • Patients with stable caregivers;
  • Willing to sign informed consent and able to comply with follow-up requirements.

Критерии исключения

  • Patients with neuropsychiatric disorders or psychological impairments;
  • Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
  • History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
  • History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
  • Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;
  • Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists;
  • Morbid obesity (BMI >40);
  • Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;
  • Current participation in other clinical trials;
  • Other conditions considered unsuitable by investigators or medical staff.

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
Оценка устройства

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Air Force Medical University — Сиань

Идентификаторы

NCT: NCT06944834 · PI2302-CL-01-002 · JJ202503-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗