MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System (NCT05936619)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (23 items).
Location: UT Southwestern Medical Center — Dallas, Texas
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UT Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 645-8003
Email: aniah.daniels@utsouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Paralysis; Quadriplegic clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.