ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Brief Title

ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Official Title

Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis

Brief Summary

      The purpose of this research study is to demonstrate that individuals with upper limb
      paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis
      and brain stem stroke can successfully achieve direct brain control of assistive devices
      using an electrocorticography (ECoG)-based brain computer interface system.
    

Detailed Description

      Brain-computer interface (BCI) technology aims to establish a direct link for transmitting
      information between the brain and external devices, offering a natural and rich control
      signal for prosthetic hands or functional electrical stimulators (FES) to re-animate
      paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity
      using electrodes implanted on the surface of the brain. Each participant will undergo testing
      of the ECoG direct brain interface for up to 29 days. Participants will learn to control
      computer cursors, virtual reality environments, and assistive devices such as hand orthoses
      and functional electrical stimulators using neural activity recorded with the ECoG sensor.
    


Study Type

Interventional


Primary Outcome

Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG

Secondary Outcome

 Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System

Condition

Tetraplegia

Intervention

Implantation of ECoG sensors on the brain surface

Study Arms / Comparison Groups

 Direct Brain Interface Users
Description:  All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

6

Start Date

May 2011

Completion Date

April 2015

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Limited or no ability to use both hands due to cervical spinal cord injury, brachial
             plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis
             (ALS) or other motor neuron diseases

          -  At least 1 year post-injury

          -  Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh
             while the ECoG electrode is implanted (up to 29 days)

          -  Additional inclusion criteria must also be reviewed

        Exclusion Criteria:

          -  Certain implanted devices

          -  Presence of other serious disease or disorder that could affect ability to participate
             in this study

          -  Additional exclusion criteria must also be reviewed
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Jennifer L Collinger, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01393444

Organization ID

PRO10010149


Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh


Study Sponsor

Jennifer L Collinger, PhD, Principal Investigator, University of Pittsburgh


Verification Date

October 2016