Brain Implant for Neural Control of a Computer
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. Two subjects will be enrolled, each implanted with the NCS for a period of 53 weeks. The study is expected to take two years in total.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Feasibility Study for Use of a Brain Implant for Neural Control of a Computer|
- Subject control of a tablet computer [ Time Frame: One year after array implantation ] [ Designated as safety issue: No ]Assessments will be compared with chance and previous reports of BMI efficacy using control signals derived from primary motor cortex. Computer-interface competency examination that measures the ability of the subject to control various aspects of the tablet user interface. Additionally we will measure the Quality of Life Inventory (QOLI) at regular intervals over the duration of the study. Changes in performance over time.
- Absence of infection or irritation [ Time Frame: One year after array implantation ] [ Designated as safety issue: Yes ]
The Serious Adverse event (SAE) rate will be calculated as the number of SAEs per implant-days. The SAE rate will be continuously compared to the 1% threshold level. CT scan; inspection of patient's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms.
Neurologic exam will be compared to baseline neurologic exam
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Neural Communication System
The Neural Communication System consists of two Neuroport Arrays, which are descried in detail in the intervention description. Both Neuroport Arrays are inserted into Brodmann's Area 5 in the posterior parietal cortex, an area of the brain used in reach planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to use thought to control a simple computer environment or a tablet computer.
Device: Neural Communication System
NeuroPort Arrays allow for the local recording of cerebral cortex. Key features include sterile, single use electrodes that provide access to a localized population of individual cells. The Neural Communication system is primarily composed of two NeuroPort Arrays. The main component of the NeuroPort Array is an array comprised of 100 microelectrodes (1.5 mm in length) uniformly organized on a 4 mm x 4 mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and has a platinum tip that is 100-200 microns in length. The Patient Pedestal is made from titanium and is 19 mm wide at the skin interface.
Other Name: NeuroPort Array
Please refer to this study by its ClinicalTrials.gov identifier: NCT01958086
|United States, California|
|University of California Los Angeles|
|Los Angeles, California, United States, 90095|
|California Institute of Technology|
|Pasadena, California, United States, 91125|
|Casa Colina Centers for Rehabilitation|
|Pomona, California, United States, 91769|
|Principal Investigator:||Richard A Andersen, PhD||California Institute of Technology|
|Principal Investigator:||Nader Pouratian, MD, PhD||University of California, Los Angeles|
|Principal Investigator:||Emily Rosario, PhD||Casa Colina Centers for Rehabilitation|