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Visuomotor Prosthetic for Paralysis

RecruitingNAAges 22 Years - 65 YearsAllRichard A. Andersen, PhD
NCT01958086 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pathology resulting in paralysis * Age 22-65 years * Able to provide informed consent * Understand and comply with instructions, if necessary, with the aid of a translator * Able to communicate via speech * Surgical clearance * Life expectancy greater than 12 months * Live within 60 miles of study location and willing to travel up to 5 days per week * A regular caregiver to monitor the surgical site * Psychosocial support system * Stable ventilator status Exclusion Criteria: * 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 * Medically uncontrolled diabetes * Autonomic dysreflexia * History of seizure * Implanted hydrocephalus shunt * History of supratentorial brain injury or neurosurgery * Medical conditions contraindicating surgery and chronic implantation of a medical device * Unable to undergo MRI or anticipated need for MRI during study * Nursing an infant or unwilling to bottle-feed infant * 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 * Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
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What it tests

  • Neural Communication System
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Where

3 sites
University of California Los Angeles
Los Angeles, United States
California Institute of Technology
Pasadena, United States
Casa Colina Centers for Rehabilitation
Pomona, 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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