Recruiting

MindEx

Sponsor:

Nader Pouratian

Code:

NCT05936619

Conditions

Paralysis; Quadriplegic

Quadraplegia

Tetraplegia

Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury

Cervical Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Mind Extender (MindEx)

Study Details

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

Quadraplegia

Tetraplegia

Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury

Cervical Spinal Cord Injury

Study ID

NCT05936619

Start date

Feb 20, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2031

Anticipated

Primary completion date

May 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Olivia Gibble, MS

214-648-8880Olivia.gibble@utsouthwestern.edu

Nader Pouratian, MD, PhD

214-645-5465nader.pouratian@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Cecile Verbaarschot, MD, PhD

2146483395Cecile.Verbaarschot@UTSouthwestern.edu

More Information

Sponsor

Nader Pouratian

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • spinal cord injury
  • brain-computer interface
  • brain-machine interface
  • paralysis
  • Quadriplegic
  • Quadraplegia
  • Tetraplegia
  • Cervical Spinal Cord Injury
  • Brainstem Stroke
  • ALS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Nader Pouratian on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.