Paralysis; QuadriplegicNCT05936619
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
A study testing Mind Extender (MindEx) in people with Paralysis; Quadriplegic and Quadraplegia, run by Nader Pouratian at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paralysis; Quadriplegic, Quadraplegia, Tetraplegia
- What is being tested?
- Mind Extender (MindEx)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2026to 1 Sep 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Cecile Verbaarschot, MD, PhD, 2146483395, Cecile.Verbaarschot@UTSouthwestern.edu
About this study
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, Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Mind Extender (MindEx)
- Keywords
- spinal cord injury, brain-computer interface, brain-machine interface, paralysis, Quadriplegic, Quadraplegia, Tetraplegia, Cervical Spinal Cord Injury, Brainstem Stroke, ALS
- Medical subject headings
- Paralysis, Quadriplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Extender (MindEx)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.
| Study group | Role | What they receive |
|---|---|---|
| Mind Extender (MindEx) | Experimental | 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. Receives: Device: Mind Extender (MindEx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous trajectory decoding
A primary objective of this study is to evaluate the effectiveness of the system in providing users the ability to continuously move a cursor on a tablet/computer.
The hypothesis is that trajectory readability from neural signals will be significantly greater than the level of chance.
Standardized tests will be used to test this objective, and performance will be compared to the level of chance.
One example of a standardized test to be used is the accuracy of continuous trajectory decoding measured by the radial-8 assessment task.
Measured: Six years after array implantation
Incidence of intervention-related adverse events
Serious adverse events (SAE) will be evaluated against a 1% threshold level. We will use regular inspection of the subjects' scalps to assess for breakdown, discharge, or infection, and use history and physical exam to evaluate for new symptoms, and compare to baseline assessments.
Measured: Six years after array implantation
Competency in computer/tablet control
An underlying hypothesis in this study is that the system will enable users the ability to control a computer/tablet interface by selecting icons.
An underlying hypothesis in the study is that neural signals will enable decoding the chosen target at higher accuracy than the level of chance.
Standardized tests will be used to test this objective, and performance will be compared to the level of chance.
An example of a standardized test to be used is the brain-control for tablet test (BCTT) which grades the accuracy of target selection by mental fixation to the level of chance.
Measured: Six years after array implantation
Efficacy of multiple brain regions for neural control over subsets of brain regions
An objective of this study is to determine whether the combination of neural signals from multiple brain regions in brain-computer interface control is more advantageous than from a subset of the brain regions being tested.
The hypothesis is that because the four brain regions being implanted each encode different cognitive functions, their integration will be more useful to brain-computer interface control, than any subset of these regions.
This objective will be tested by standardized tests (such as those mentioned for "Competency in computer/tablet control" and "Continuous trajectory decoding") in different groups of brain regions and reported for each, such as:
- All four brain regions: prefrontal cortex (PFC), posterior parietal cortex (PPC), dorsal premotor cortex (PMd), primary motor cortex (M1)
- PMd,PPC, and M1
- PPC and M1 alone
Measured: Six years after array implantation
Secondary outcomes (1)
Change in quality of life
The functional change in quality of life will be evaluated through a Quality-of-Life Inventory (QOLI) administered periodically throughout the study. This is a 32-item questionnaire with a score range from 1-77, with higher scores reflecting higher satisfaction.
Measured: Time Frame: Annually, for six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start20 Feb 2026
- Primary completion30 May 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralysis; QuadriplegicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Pouratian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nader Pouratian, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936619
- Sponsor's protocol ID
- STU-2023-0306
- Status last verified
- Sep 2026
- First submitted
- 25 May 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Investigators with established research programs will be eligible for data sharing. Interested investigators will be required to submit a summary of the proposed work and requested data elements. If approved by the Principal Investigator of the study, data will be shared. This data will be de-identified and coded. There is no plan to share identifiers outside the study team.