MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System

Обзор

This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer. This technology is named MindEx (for Mind Extender). It utilizes four implanted "chips" in the human brain from which investigators can record brain activity during subjects' thoughts and decode meaningful information from this activity to be used as control signals for a computer, a laptop, or a tablet. The use of four brain regions is a significant differentiating feature and scientific innovation of this study over much prior work in this space, that typically derived control signals from one, or sometimes two brain regions. The brain regions to be used here can allow the decode of multiple variables simultaneously, including not just moment-to-moment position, but also high-level goals, intentions, decisions, scene comprehension, and error-related signals involved in natural human behavior. The research is being done through a prospective, longitudinal, single-arm early feasibility study to examine the safety and effectiveness of using MindEx to provide the user an intuitive, efficient, and accurate ability to control multiple applications on a computer interface such as a word processor, a paint application, or to play simple video games. Such versatility could greatly improve the autonomy and quality of life of severely paralyzed individuals. Two subjects will be enrolled, each implanted with MindEx for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.

Вмешательства

• Устройство Mind Extender (MindEx)
  NeuroPort Multi-Port Arrays allow for the local recording of cerebral cortex. The Mind Extender (MindEx) system is primarily composed of two NeuroPort Multi-Port Arrays. Each Multi-Port device consists of two arrays, each with 100 electrodes in a 10 x 10 configuration, with dimensions 4 mm x 4 mm x 1.5 mm (W x H x D), and a titanium percutaneous connector, 19 mm diameter at the base. Each MultiPort can have a total of 128 active channels (capable of transmitting neural signals to the percutaneou

Первичные конечные точки

• Continuous trajectory decoding [Срок оценки: Six years after array implantation]
• Incidence of intervention-related adverse events [Срок оценки: Six years after array implantation]
• Competency in computer/tablet control [Срок оценки: Six years after array implantation]
• Efficacy of multiple brain regions for neural control over subsets of brain regions [Срок оценки: Six years after array implantation]

Вторичные конечные точки (1)

• Change in quality of life [Срок оценки: Time Frame: Annually, for six years]

Критерии участия

Критерии включения

• Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)
• Provide informed consent
• Understand and comply with instructions, if necessary, with the aid of a translator
• Communicate via speech or other means
• Surgical clearance
• Life expectancy greater than 12 months
• Travel to study locations up to five days per week for the duration of the study
• Caregiver monitor for surgical site complications and behavioral changes on a daily basis
• Psychosocial support system
• Stable ventilator status

Критерии исключения

• Presence of memory problems
• Intellectual impairment
• Psychotic illness or chronic psychiatric disorder, including major depression if untreated
• Poor visual acuity
• Pregnancy
• Active infection or unexplained fever
• Scalp lesions or skin breakdown
• HIV or AIDS infection
• Active cancer or chemotherapy
• Diabetes
• Autonomic dysreflexia
• History of seizure
• Implanted hydrocephalus shunt
• Prior cranioplasty
• Other implanted devices
• Medical conditions contraindicating surgery and chronic implantation of a medical device
• Unable to undergo MRI or anticipated need for MRI during the study
• Breastfeeding an infant (direct nursing or via a bottle of expressed milk)
• Chronic oral or intravenous use of steroids or immunosuppressive therapy
• Suicidal ideation
• Drug or alcohol dependence
• Planning to become pregnant, or unwilling to use adequate birth control

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

США · 1 центр

• UT Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT05936619 · STU-2023-0306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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