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Идёт набор NCT07127172

GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Без фазы С лечением Tetraplegia/Tetraparesis Quadriplegia Quadriplegia/Tetraplegia Cervical Spinal Cord Injury

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: N1 Implant, R1 Robot.
Кому может быть актуально
Состояния в реестре: Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury. Базовые параметры: от 18 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
Великобритания
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 GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions. The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.

Вмешательства

  • Устройство N1 Implant
    The N1 Implant is a type of implantable brain-computer interface.
  • Устройство R1 Robot
    The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Первичные конечные точки

  • The Rate of Device-Related Adverse Events (AE) [Срок оценки: 12 months post-implant]
  • The Rate of Procedure-Related Adverse Events (AE) [Срок оценки: 12 months post-implant]
Вторичные конечные точки (8)
  • The Rate of Device-Related Adverse Events (AE) [Срок оценки: Up to 48 months post-implant]
  • The Rate of Procedure-Related Adverse Events (AE) [Срок оценки: Up to 48 months post-implant]
  • Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study [Срок оценки: From baseline to 3-, 6-, 9-, and 12-months post-implantation]
  • Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase [Срок оценки: From baseline to 48-months post-implantation]
  • Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study [Срок оценки: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation]
  • Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase [Срок оценки: From baseline to 48-months post-implantation]
  • Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study [Срок оценки: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation]
  • Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase [Срок оценки: From baseline to 48-months post-implantation]

Критерии участия

Критерии включения

  • (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.

OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.

  • Life expectancy ≥ 12 months.
  • Ability to communicate in English
  • Presence of a stable caregiver

Критерии исключения

  • Moderate to high risk for serious perioperative adverse events
  • Active implanted devices
  • Morbid obesity (Body Mass Index > 40)
  • History of poorly controlled seizures or epilepsy
  • History of poorly controlled diabetes
  • Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
  • Acquired or hereditary immunosuppression
  • Use of smoking tobacco or other tobacco products
  • Psychiatric or psychological disorder
  • Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
  • Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

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

Великобритания · 2 центра
  • University College London Hospitals NHS Foundation Trust — London
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne

Идентификаторы

NCT: NCT07127172 · N1-EFS-006 · 354112

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗