[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Richard A. Andersen, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100205982","visuomotor-prosthetic-for-paralysis-100205982",false,"NCT01958086","Visuomotor Prosthetic for Paralysis","Inclusion Criteria:\n\n* Pathology resulting in paralysis\n* Age 22-65 years\n* Able to provide informed consent\n* Understand and comply with instructions, if necessary, with the aid of a translator\n* Able to communicate via speech\n* Surgical clearance\n* Life expectancy greater than 12 months\n* Live within 60 miles of study location and willing to travel up to 5 days per week\n* A regular caregiver to monitor the surgical site\n* Psychosocial support system\n* Stable ventilator status\n\nExclusion Criteria:\n\n* Intellectual impairment\n* Psychotic illness or chronic psychiatric disorder, including major depression if untreated\n* Poor visual acuity\n* Pregnancy\n* Active infection or unexplained fever\n* Scalp lesions or skin breakdown\n* HIV or AIDS infection\n* Active cancer or chemotherapy\n* Medically uncontrolled diabetes\n* Autonomic dysreflexia\n* History of seizure\n* Implanted hydrocephalus shunt\n* History of supratentorial brain injury or neurosurgery\n* Medical conditions contraindicating surgery and chronic implantation of a medical device\n* Unable to undergo MRI or anticipated need for MRI during study\n* Nursing an infant or unwilling to bottle-feed infant\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Suicidal ideation\n* Drug or alcohol dependence\n* Planning to become pregnant, or unwilling to use adequate birth control\n* Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.","ALL","22 Years","65 Years",{"count":5,"type":19},"ESTIMATED","INTERVENTIONAL",[22],"NA","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.",[25],"Quadriplegia",[27,28,29,30,31,32,33,34,35],"Neural","Prosthetic","brain machine interface","brain computer interface","brain control","paralysis","tetraplegia","quadriplegia","spinal cord injury","RECRUITING","2026-03-16",{"date":39,"type":40},"2026-03-18","ACTUAL",{"date":42,"type":40},"2013-10-01",{"date":44,"type":19},"2031-07-31",{"name":46,"class":47},"Richard A. Andersen, PhD","OTHER",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100206454","sensory-motor-transformations-in-human-cortex-100206454","NCT01964261","Sensory Motor Transformations in Human Cortex","A Feasibility Study of the Ability of the Neural Prosthetic System 2 to Provide Direct Closed Loop Cortical Control of Extracorporeal Devices Through the Use of Intracortical Microstimulation in Patients With Quadriplegia","Inclusion Criteria:\n\n* High cervical spinal lesion\n* Age 22-65\n* Able to provide informed consent\n* Able to understand and comply with instructions in English\n* Communicate via speech\n* Surgical clearance\n* Life expectancy greater than 12 months\n* Travel up to 60 miles to study locations up to five days per week\n* Caregiver monitor for surgical site complications and behavioral changes on a daily basis\n* Psychosocial support system\n\nExclusion Criteria:\n\n* Presence of memory problems\n* Intellectual impairment\n* Psychotic illness or chronic psychiatric disorder, including major depression if untreated\n* Poor visual acuity\n* Pregnancy\n* Active infection or unexplained fever\n* Scalp lesions or skin breakdown\n* HIV or AIDS infection\n* Active cancer or chemotherapy\n* Diabetes\n* Autonomic dysreflexia\n* History of seizure\n* Implanted hydrocephalus shunt\n* Previous neurosurgical history affecting parietal lobe function\n* Medical conditions contraindicating surgery and chronic implantation of a medical device\n* Prior cranioplasty\n* Unable to undergo MRI or anticipated need for MRI during study\n* Nursing an infant or unwilling to bottle-feed infant\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Suicidal ideation\n* Drug or alcohol dependence\n* Planning to become pregnant, or unwilling to use adequate birth control\n* Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.\n* Implanted deep brain stimulator (DBS), DBS leads, or cochlear implant.",{"count":57,"type":19},5,[22],"This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback.\n\nDevelopment of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb.\n\nA key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and\u002For fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to \"feel\" what the robotic arm is touching.\n\nThe device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf.\n\nThe investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.",[25],[27,28,62,30,31,32,33,34,35,63,64],"Brain machine interface","stimulation","sensory feedback","2025-05-20",{"date":67,"type":40},"2025-05-22",{"date":69,"type":40},"2013-11-01",{"date":71,"type":19},"2027-01-31",{"name":46,"class":47},4,""]