Functional Outcomes and Control Using Synchron BCI - Canada

Обзор

Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)

Подробное описание

Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN):

The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for adults with bilateral upper-limb motor impairment, including Motor Neuron Disease. 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.

The Synchron BCI is an implanted BCI device that interfaces with the brain to enable control of digital devices in individuals with bilateral upper-limb motor impairment. The Synchron BCI is designed to record volitional motor-related neural signals from the sensorimotor cortices and translate these signals into digital motor outputs to enable control of digital devices to improve functional independence. The system includes both implantable and non-implantable components. Implantable components are the Stentrode and the Transceiver.

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 resulting in death or permanently increased disability up to 90 days after implant. [Срок оценки: 3 Months]

Вторичные конечные точки (3)

• Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant. [Срок оценки: 12 Months]
• Target vessel patency assessed using CT venography at 90 and 365 days after implant. [Срок оценки: 3 Months and 12 Months]
• Device migration assessed using CT venography at 90 and 365 days after implant. [Срок оценки: 3 Months and 12 Months]

Критерии участия

Критерии включения

• Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).
• Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.
• Aged 18 years or older.
• Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).
• Preserved precentral gyrus assessed using CT.
• Suitable vascular anatomy, in the opinion of the Investigator(s), assessed using CT venography.
• Suitable anatomy for subcutaneous pocket creation.
• Able to undergo anesthesia.
• Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.
• Caregiver(s) willing and able to facilitate study visits, including visits at 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, including an internet connection.

Критерии исключения

• Unrealistic expectations regarding the potential benefits of the device, in the opinion of the Investigator(s).
• 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 (e.g., severe depression, psychotic features, personality disorder, severe emotional lability, substance abuse), in the opinion of the Investigator(s).
• Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).
• 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 (listed in Physician Implant Manual).
• 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) or recurrent history of venous thromboembolic disease.
• Contraindication to antithrombotic therapy, in the opinion of the Investigator(s).
• 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.
• Currently receiving or expected to require medical treatment that may be precluded by device implant, including magnetic resonance imaging, transcranial magnetic stimulation, electroconvulsive therapy, transcranial ultrasound, shortwave, microwave, and/or therapeutic ultrasound diathermy, or balloon angioplasty or stenting in the target vessel.
• 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.
• Patients with ALS due to SOD1 mutations on gene therapy.
• Any other disease or disorder that could significantly affect participation in the study, in the opinion of the Investigator(s). 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

Канада · 2 центра

• Sunnybrook Health Sciences Centre — Toronto
• St. Michael's Hospital — Toronto

Идентификаторы

NCT: NCT07446114 · S-03-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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