MindEx multifocal cognitive brain‑machine interface for people with severe paralysis
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
NA · University of Texas Southwestern Medical Center · NCT05936619
This trial will test the MindEx system, which uses four tiny implanted brain chips to let people with severe paralysis control a computer or tablet with their thoughts.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05936619 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with quadriplegia from cervical spinal cord injury, brainstem stroke, or ALS who can give informed consent, are surgically eligible, have caregiver and psychosocial support, and can travel to the Dallas site regularly.
Not a fit: People with memory or intellectual impairment, untreated major psychiatric illness, active infections, certain medical conditions listed in the exclusions (for example diabetes, active cancer, HIV/AIDS, pregnancy), scalp lesions, a history of uncontrolled seizures, or who cannot undergo surgery or frequent travel are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, MindEx could restore meaningful computer control and communication for people with severe paralysis, increasing independence and quality of life.
How similar studies have performed: Previous single- and two-site intracortical BCIs have demonstrated proof-of-concept for communication and device control, but using four implanted chips across multiple brain regions is a novel approach with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Aniah Daniels, BS
- Email: aniah.daniels@utsouthwestern.edu
- Phone: 214-645-8003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Paralysis, Quadriplegic, spinal cord injury, brain-computer interface, brain-machine interface