Visuomotor Prosthetic for Paralysis

ConditionQuadriplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorRichard A. Andersen, PhD

About this trial

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

Qualifiers

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

Disqualifiers

Intellectual impairment

Psychotic illness or chronic psychiatric disorder, including major depression if untreated

Poor visual acuity

Pregnancy

Trial design

Treatments tested in this trial

  • Neural Communication System

Treatment groups

2 Participants
are divided into 1 treatment group

Sponsors and collaborators

Richard A. Andersen, PhD

Lead sponsor

California Institute of Technology

Sponsor institution

University of California, Los Angeles

Collaborator

Casa Colina Hospital and Centers for Healthcare

Collaborator