Home › Quadriplegia › NCT01958086
Visuomotor Prosthetic for Paralysis
Who can join
Ages 22 to 65 · All sexes
Full eligibility criteria
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.
About the study
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 patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of "smart" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS 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.
What is being tested
- Neural Communication System (device)
Sponsor: Richard A. Andersen, PhD · Participants: 2 · Started: Oct 1, 2013
Contact the study team
- Ausaf Bari, MD, PhD · Phone: 310-825-5111
- Emily Rosario, PhD · Phone: 909.596.7733
Official record on ClinicalTrials.gov — NCT01958086
Locations in the U.S.
| California | University of California Los Angeles, Los Angeles California Institute of Technology, Pasadena Casa Colina Centers for Rehabilitation, Pomona |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.