ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

This study is currently recruiting participants.
Verified June 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Wei Wang, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01393444
First received: July 11, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The purpose of this research study is to demonstrate that individuals with upper limb paralysis, such as tetraplegia due to spinal cord injury, can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.


Condition Intervention
Tetraplegia
Spinal Cord Injury
Muscular Dystrophy
ALS
Brainstem Stroke
Device: Implantation of ECoG sensors on the brain surface

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary outcome is the successful control of a variety of external devices using neural data recorded with ECoG. [ Time Frame: Up to 29 days of device implantation ] [ Designated as safety issue: No ]
    Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.


Secondary Outcome Measures:
  • A secondary outcome is to demonstrate that individuals with upper limb paralysis can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain-computer interface system. [ Time Frame: Up to 29 days of device implantation ] [ Designated as safety issue: No ]
    Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.


Estimated Enrollment: 3
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Direct Brain Interface Users
All participants enrolled in the study will be individuals implanted with an ECoG sensor on the surface of their brain to record neural activity. There is no control group.
Device: Implantation of ECoG sensors on the brain surface
One ECoG sensor will be implanted over the motor cortex of study participants
Other Names:
  • brain-computer interface
  • neuroprosthetic

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Limited or no ability to use both hands due to cervical spinal cord 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393444

Contacts
Contact: Debbie Harrington 412-383-1355 harringtond2@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Debbie E Harrington    412-383-1355    harringtond2@upmc.edu   
Principal Investigator: Wei Wang, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Wei Wang, MD, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Wei Wang, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01393444     History of Changes
Other Study ID Numbers: PRO10010149
Study First Received: July 11, 2011
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Electrocorticography
Tetraplegia
Spinal cord injury
Brainstem stroke
Neuroprosthetic
Brain-computer interface
Direct brain interface
Neural activity
Motor cortex

Additional relevant MeSH terms:
Muscular Dystrophies
Quadriplegia
Spinal Cord Injuries
Stroke
Brain Stem Infarctions
Paralysis
Wounds and Injuries
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 22, 2014