Trial record 9 of 39 for:    Open Studies | "Quadriplegia"

Brain Implant for Neural Control of a Computer

This study is currently recruiting participants.
Verified October 2013 by California Institute of Technology
Sponsor:
Collaborators:
University of California, Los Angeles
Casa Colina Centers for Rehabilitation
Information provided by (Responsible Party):
Richard A. Andersen, PhD, California Institute of Technology
ClinicalTrials.gov Identifier:
NCT01958086
First received: October 4, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Quadriplegia
Device: Neural Communication System

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by California Institute of Technology:

Primary Outcome Measures:
  • 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



Estimated Enrollment: 2
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01958086

Contacts
Contact: Nader Pouratian, MD, PhD 310-206-2189 NPouratian@mednet.ucla.edu
Contact: Emily Rosario, PhD 909.596.7733 ext 3036 ERosario@casacolina.org

Locations
United States, California
University of California Los Angeles Active, not recruiting
Los Angeles, California, United States, 90095
California Institute of Technology Active, not recruiting
Pasadena, California, United States, 91125
Casa Colina Centers for Rehabilitation Recruiting
Pomona, California, United States, 91769
Contact: Emily Rosario, PhD    909-596-7733 ext 3036    erosario@casacolina.org   
Sponsors and Collaborators
Richard A. Andersen, PhD
University of California, Los Angeles
Casa Colina Centers for Rehabilitation
Investigators
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
  More Information

No publications provided

Responsible Party: Richard A. Andersen, PhD, James G. Boswell Professor of Neuroscience, California Institute of Technology
ClinicalTrials.gov Identifier: NCT01958086     History of Changes
Other Study ID Numbers: G120287, 13-000576
Study First Received: October 4, 2013
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by California Institute of Technology:
Neural
Prosthetic
brain machine interface
brain computer interface
brain control
paralysis
tetraplegia
quadriplegia
spinal cord injury

Additional relevant MeSH terms:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014