MindEx: Brain-Computer Interface for Paralysis
This study is testing a new brain-computer interface (BCI) system called MindEx. It uses four small implanted "chips" (NeuroPort Multi-Port Arrays) in your brain to record your thoughts. This brain activity is then used to control a computer, laptop, or tablet, helping people with severe paralysis interact with the world. The study is looking for two participants, aged 18 to 65, who have paralysis from a spinal cord injury, brainstem stroke, or ALS. To be considered successful, the study will measure how well participants can control a computer and any side effects over six years after the device is implanted. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of two participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for six years after the device is implanted to assess computer control and any adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Continuous trajectory decodingSix years after array implantation
A primary objective of this study is to evaluate the effectiveness of the system in providing users the ability to continuously move a cursor on a tablet/computer. The hypothesis is that trajectory readability from neural signals will be significantly greater than the level of chance. Standardized tests will be used to test this objective, and performance will be compared to the level of chance. One example of a standardized test to be used is the accuracy of continuous trajectory decoding measured by the radial-8 assessment task.
- Incidence of intervention-related adverse eventsSix years after array implantation
Serious adverse events (SAE) will be evaluated against a 1% threshold level. We will use regular inspection of the subjects' scalps to assess for breakdown, discharge, or infection, and use history and physical exam to evaluate for new symptoms, and compare to baseline assessments.
- Competency in computer/tablet controlSix years after array implantation
An underlying hypothesis in this study is that the system will enable users the ability to control a computer/tablet interface by selecting icons. An underlying hypothesis in the study is that neural signals will enable decoding the chosen target at higher accuracy than the level of chance. Standardized tests will be used to test this objective, and performance will be compared to the level of chance. An example of a standardized test to be used is the brain-control for tablet test (BCTT) which grades the accuracy of target selection by mental fixation to the level of chance.
- Efficacy of multiple brain regions for neural control over subsets of brain regionsSix years after array implantation
An objective of this study is to determine whether the combination of neural signals from multiple brain regions in brain-computer interface control is more advantageous than from a subset of the brain regions being tested. The hypothesis is that because the four brain regions being implanted each encode different cognitive functions, their integration will be more useful to brain-computer interface control, than any subset of these regions. This objective will be tested by standardized tests (such as those mentioned for "Competency in computer/tablet control" and "Continuous trajectory decoding") in different groups of brain regions and reported for each, such as: 1. All four brain regions: prefrontal cortex (PFC), posterior parietal cortex (PPC), dorsal premotor cortex (PMd), primary motor cortex (M1) 2. PMd,PPC, and M1 3. PPC and M1 alone