Clinical Trial: Brain Implant for Neural Control of a Computer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Feasibility Study for Use of a Brain Implant for Neural Control of a Computer

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. 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.

Detailed Summary:
Sponsor: Richard A. Andersen, PhD

Current Primary Outcome:

• Subject control of a tablet computer [ Time Frame: One year after array implantation ]
  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 ]

  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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: California Institute of Technology

Dates:
Date Received: October 4, 2013
Date Started: October 2013
Date Completion: December 2018
Last Updated: April 14, 2017
Last Verified: April 2017