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

NCT ID: NCT05936619

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2031-09-01

Brief Summary

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.

Conditions

Paralysis; Quadriplegic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Mind Extender (MindEx)

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.

Group Type: EXPERIMENTAL

Mind Extender (MindEx)

Intervention Type: DEVICE

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 percutaneous connector) across the two arrays. In our design, we will split active channels evenly between the two arrays resulting in 64 active channels per array. The four arrays of the two Multi-Port device will be implanted into prefrontal cortex, premotor cortex, primary motor cortex, and posterior parietal cortex.

Interventions

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 percutaneous connector) across the two arrays. In our design, we will split active channels evenly between the two arrays resulting in 64 active channels per array. The four arrays of the two Multi-Port device will be implanted into prefrontal cortex, premotor cortex, primary motor cortex, and posterior parietal cortex.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nader Pouratian

OTHER

Sponsor Role: lead

Responsible Party

Nader Pouratian

Professor & Chair

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Central Contacts

Aniah Daniels, BS

Role: CONTACT

aniah.daniels@utsouthwestern.edu

214-645-8003

Nader Pouratian, MD, PhD

Role: CONTACT

nader.pouratian@utsouthwestern.edu

214-645-5465

Facility Contacts

Srinivas Chivukula, MD, PhD

Role: primary

srinivas.chivukula@utsouthwestern.edu

214-645-8300

Other Identifiers

STU-2023-0306

Identifier Type: -

Identifier Source: org_study_id