NCT05936619

MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Nader Pouratian · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-02-20
• Primary completion: 2030-05-30
• Completion: 2031-09-01
• First posted: 2023-07-10
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study