RECRUITING

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

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Conditions

TetraplegiaSpinal Cord InjuriesAmyotrophic Lateral SclerosisBrain Stem InfarctionsLocked in SyndromeMuscular DystrophyBrain computer interfaceAssistive deviceEnvironmental controlCommunication devicequadriplegia

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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 purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Official Title

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Quick Facts

Study Start:2009-05
Study Completion:2038-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00912041

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:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
  2. * Complete or incomplete tetraplegia (quadriplegia)
  3. * Must live within a three-hour drive of the Study site
  4. * (There are additional inclusion criteria)
  1. * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
  2. * Chronic oral or intravenous steroids or immunosuppressive therapy
  3. * Other serious disease or disorder that could seriously affect ability to participate in the study
  4. * (There are additional exclusion criteria)

Contacts and Locations

Study Contact

Leigh R Hochberg, M.D., Ph.D.
CONTACT
617-724-9247
clinicaltrials@braingate.org

Principal Investigator

Leigh R Hochberg, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

University of California, Davis
Sacramento, California, 95817
United States
Stanford University School of Medicine
Stanford, California, 94305
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Providence VA Medical Center
Providence, Rhode Island, 02908
United States

Collaborators and Investigators

Sponsor: Leigh R. Hochberg, MD, PhD.

  • Leigh R Hochberg, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2009-05
Study Completion Date2038-12

Study Record Updates

Study Start Date2009-05
Study Completion Date2038-12

Terms related to this study

Keywords Provided by Researchers

  • Brain computer interface
  • Assistive device
  • Environmental control
  • Communication device
  • quadriplegia
  • tetraplegia

Additional Relevant MeSH Terms

  • Tetraplegia
  • Spinal Cord Injuries
  • Amyotrophic Lateral Sclerosis
  • Brain Stem Infarctions
  • Locked in Syndrome
  • Muscular Dystrophy