RECRUITING

Visuomotor Prosthetic for Paralysis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Visuomotor Prosthetic for Paralysis

Quick Facts

Study Start:2013-10-01
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01958086

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathology resulting in paralysis
  2. * Age 22-65 years
  3. * Able to provide informed consent
  4. * Understand and comply with instructions, if necessary, with the aid of a translator
  5. * Able to communicate via speech
  6. * Surgical clearance
  7. * Life expectancy greater than 12 months
  8. * Live within 60 miles of study location and willing to travel up to 5 days per week
  9. * A regular caregiver to monitor the surgical site
  10. * Psychosocial support system
  11. * Stable ventilator status
  1. * Intellectual impairment
  2. * Psychotic illness or chronic psychiatric disorder, including major depression if untreated
  3. * Poor visual acuity
  4. * Pregnancy
  5. * Active infection or unexplained fever
  6. * Scalp lesions or skin breakdown
  7. * HIV or AIDS infection
  8. * Active cancer or chemotherapy
  9. * Medically uncontrolled diabetes
  10. * Autonomic dysreflexia
  11. * History of seizure
  12. * Implanted hydrocephalus shunt
  13. * History of supratentorial brain injury or neurosurgery
  14. * Medical conditions contraindicating surgery and chronic implantation of a medical device
  15. * Unable to undergo MRI or anticipated need for MRI during study
  16. * Nursing an infant or unwilling to bottle-feed infant
  17. * Chronic oral or intravenous use of steroids or immunosuppressive therapy
  18. * Suicidal ideation
  19. * Drug or alcohol dependence
  20. * Planning to become pregnant, or unwilling to use adequate birth control
  21. * Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.

Contacts and Locations

Study Contact

Ausaf Bari, MD, PhD
CONTACT
310-825-5111
ABari@mednet.ucla.edu
Emily Rosario, PhD
CONTACT
909.596.7733
ERosario@casacolina.org

Principal Investigator

Richard A Andersen, PhD
PRINCIPAL_INVESTIGATOR
California Institute of Technology
Ausaf Bari, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Emily Rosario, PhD
PRINCIPAL_INVESTIGATOR
Casa Colina Hospital and Centers for Healthcare

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90095
United States
California Institute of Technology
Pasadena, California, 91125
United States
Casa Colina Centers for Rehabilitation
Pomona, California, 91769
United States

Collaborators and Investigators

Sponsor: Richard A. Andersen, PhD

  • Richard A Andersen, PhD, PRINCIPAL_INVESTIGATOR, California Institute of Technology
  • Ausaf Bari, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Emily Rosario, PhD, PRINCIPAL_INVESTIGATOR, Casa Colina Hospital and Centers for Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-10-01
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2013-10-01
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Neural
  • Prosthetic
  • brain machine interface
  • brain computer interface
  • brain control
  • paralysis
  • tetraplegia
  • quadriplegia
  • spinal cord injury

Additional Relevant MeSH Terms

  • Quadriplegia