MindEx multifocal cognitive brain‑machine interface for people with severe paralysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MindEx implants four recording chips in different brain regions to capture multiple signals, including moment-to-moment movement intent, high-level goals, and error-related signals, and decodes those signals to generate control commands for a computer, laptop, or tablet. Participants will be adults with severe paralysis from cervical spinal cord injury, brainstem stroke, or ALS who are cleared for surgery, can consent, and can travel to UT Southwestern frequently for training and testing. The protocol requires implantation, regular clinic visits (up to five days per week), and caregiver support for postoperative monitoring. The multifocal approach of using four brain regions is a key innovation compared with prior intracortical BCIs that typically used one or two sites.

Why it matters

Who can join: the full rules

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

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Olivia Gibble, MS
• Email: Olivia.gibble@utsouthwestern.edu
• Phone: 214-648-8880

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a brain-computer interface to help people with tetraplegia communicate

  This study is testing a new brain-computer interface to help people with tetraplegia communicate more easily using a tablet.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT06511934

• Robotic implantation of a precise brain‑computer interface to restore communication

  This project tests whether a robotically implanted Neuralink N1 brain implant can help adults with severe, irreversible speech loss from ALS, spinal cord injury, or stroke communicate again.

  Recruiting Neuralink Corp · Dallas, Texas · NCT07224256

• Robotically implanted Neuralink N1 brain-computer interface to control external devices

  This study will test whether a robotically implanted Neuralink N1 brain-computer interface can safely help people with high spinal cord injuries or ALS control computers and other external devices.

  Recruiting at 2 sites Neuralink Corp · London, Greater London and 1 other locations · NCT07127172

• Robotically implanted brain chip to help control external devices

  This tests a wireless, rechargeable brain implant (Neuralink N1) and a robot surgical system (R1) to help people with severe arm and hand paralysis control external devices.

  Recruiting Neuralink Corp · Abu Dhabi · NCT06992596

• Robotically implanted brain-computer interface for controlling devices

  This study is testing a new brain implant and robot to see if they can help people with severe movement limitations control devices more easily.

  Recruiting Neuralink Corp · Toronto, Ontario · NCT06700304

• Improving hand function in cervical spinal cord injury with nerve transfers and electrical stimulation

  This study is testing if using electrical stimulation during and after nerve surgery can help people with cervical spinal cord injuries regain hand function and feel less pain.

  Recruiting Stanford University · Palo Alto, California · NCT06541041

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.