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

Nader Pouratian

Status: Begins enrollment in 1 month

Conditions: Paralysis; Quadriplegic

Treatments: Device: Mind Extender (MindEx)

Study type: Interventional

Funder types: Other

Identifiers

NCT05936619

STU-2023-0306

Details and patient eligibility

About

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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Mind Extender (MindEx)

Experimental group

Description:

MindEx consists of two Neuroport Multi-Port Arrays, described in detail in the intervention description. Each NeuroPort Multi-Port Array comprises two electrode arrays implanted into human brain tissue, for a total of four electrode arrays. These will be in 1) prefrontal cortex, a brain area involved in scene comprehension, action selection, and error signaling, 2) premotor cortex, a brain area involved in planning ongoing and upcoming actions, 3) posterior parietal cortex, a brain area involved in processing sensory-to-motor transformations during movements, and 4) primary motor cortex, responsible for controlling movement. The pair of electrode arrays in each NeuroPort Multi-Port Array connect to a single percutaneous pedestal attached to the skull during a surgical procedure. Following recovery from the surgical placement, subjects will participate in study sessions up to 5 times a week. They will learn to use thought to control applications on a computer, a laptop, or a tablet.

Treatment:

Device: Mind Extender (MindEx)