Tests a brain implant that lets paralyzed people control a computer with thoughts

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 who are severely paralyzed because of a cervical spinal cord injury, a brainstem stroke or ALS. Two people will receive a brain implant to control a computer.

Age

18 Years to 65 Years

Sex

All sexes can join.

Disease stage

Paralysis caused by cervical spinal cord injury, brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS). Stable ventilator status. Life expectancy greater than 12 months.

Earlier treatment

No chronic oral or intravenous steroids or immunosuppressive therapy. No prior cranioplasty. No implanted hydrocephalus shunt or other implanted devices.

Main reasons for not taking part

• Memory problems, intellectual impairment, or psychotic or chronic psychiatric illness
• Pregnancy, breastfeeding, or planning to become pregnant
• HIV or AIDS infection, active infection, active cancer or chemotherapy, or diabetes
• History of seizure or autonomic dysreflexia
• Cannot have an MRI, or an MRI is expected to be needed during the study

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• Mind Extender (MindEx)Treatment being tested

  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.