Summary

Eligibility
for people ages 22-65 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Nader Pouratian, MD, PhD (ucla)

Description

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.

Official Title

Feasibility Study for Use of a Brain Implant for Neural Control of a Computer

Keywords

Quadriplegia Neural Prosthetic brain machine interface brain computer interface brain control paralysis tetraplegia spinal cord injury Neural Communication System

Eligibility

You can join if…

Open to people ages 22-65

  • High cervical spinal lesion
  • Age 22-65 years
  • Able to provide informed consent
  • Able to understand and comply with instructions in English
  • 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
  • Ventilator independent

You CAN'T join if...

  • 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
  • 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.

Locations

  • University of California Los Angeles in progress, not accepting new patients
    Los Angeles California 90095 United States
  • California Institute of Technology in progress, not accepting new patients
    Pasadena California 91125 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Richard A. Andersen, PhD
ID
NCT01958086
Study Type
Interventional
Last Updated