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

RecruitingNAAges 18 Years - 65 YearsAllNader Pouratian
NCT05936619 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
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
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What it tests

  • Mind Extender (MindEx)
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Where

1 site
UT Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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