INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study

Обзор

INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study

Подробное описание

The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for individuals with bilateral upper-limb motor impairment, such as Amyotrophic Lateral Sclerosis (ALS). The Synchron BCI is intended to replace the function of motor neurons by detecting, translating and transmitting motor-related brain signals to restore clinically meaningful control of digital devices.

Вмешательства

• Устройство Stentrode
  The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.

Первичные конечные точки

• Device-related serious adverse events up to 180 days after implant [Срок оценки: 6 Months]

Вторичные конечные точки (3)

• Device-related serious adverse events up to 1 year after implant [Срок оценки: 12 Months]
• Target vessel patency assessed using CT venography at 180 days and 364 days after implant [Срок оценки: 6 Months and 12 Months]
• Device migration assessed using CT images at 180 days and 365 days after implant [Срок оценки: 6 Months and 12 Months]

Критерии участия

Критерии включения

• Able to provide informed consent to participate in the study.
• Diagnosis of ALS, with bilateral upper-limb paresis.
• ALS must be refractory to treatment and have been present for a minimum of six months.
• Aged 22 years or older.
• Life expectancy greater than 12 months post-implantation.
• Preserved precentral gyrus assessed using CT.
• Suitable vascular anatomy assessed using CT venography.
• Suitable anatomy for subcutaneous pocket creation.
• Able to undergo anesthesia.
• Willing and able to comply with all investigational requirements, including clinical testing visits and training visits in the home.
• Caregiver(s) willing and able to facilitate study visits, including visits to the study site and in the home, and BCI use outside of study visits (e.g., device charging).
• Patient and caregiver fluent in English.
• Suitable home environment for BCI training.

Критерии исключения

• Active infection or unexplained fever in the 48 hours prior to informed consent.
• Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
• Diagnosis of ALS-FTD or another dementia.
• Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).
• Known allergy to patient-contacting materials included in the implanted device.
• Contraindication to angiographic imaging or iodine contrast media.
• History of central venous sinus thrombosis.
• Recent history of new venous thromboembolic event (in the 6 months prior to implant), recurrent history of venous thromboembolic disease, or hypercoagulable state.
• Contraindication to antithrombotic therapy.
• Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.
• Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.
• Pregnant or breast feeding.
• Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.
• Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.

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

США · 5 центров

• Mayo Clinic — Jacksonville
• University of Buffalo Neurosurgery — Buffalo
• Mount Sinai Hospital — New York
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh
• University of Texas Southwestern Medical Center (UTSW) — Dallas

Идентификаторы

NCT: NCT07543367 · S-03-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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