| NCT ID | NCT01958086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Richard A. Andersen, PhD |
| Condition | Quadriplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 2 participants |
| Start Date | 2013-10-01 |
| Primary Completion | 2031-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2 participants in total. It began in 2013-10-01 with a primary completion date of 2031-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Richard A Andersen, PhD
PRINCIPAL INVESTIGATOR
California Institute of Technology
Frequently Asked Questions
Who can join the NCT01958086 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 65 Years, studying Quadriplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01958086 currently recruiting?
Yes, NCT01958086 is actively recruiting participants. Contact the research team at ABari@mednet.ucla.edu for enrollment information.
Where is the NCT01958086 trial being conducted?
This trial is being conducted at Los Angeles, United States, Pasadena, United States, Pomona, United States.
Who is sponsoring the NCT01958086 clinical trial?
NCT01958086 is sponsored by Richard A. Andersen, PhD. The principal investigator is Richard A Andersen, PhD at California Institute of Technology. The trial plans to enroll 2 participants.