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ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

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ClinicalTrials.gov Identifier: NCT01393444
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Jennifer Collinger, PhD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE July 11, 2011
First Posted Date  ICMJE July 13, 2011
Results First Submitted Date  ICMJE August 17, 2016
Results First Posted Date  ICMJE December 12, 2016
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG [ Time Frame: Up to 29 days of device implantation ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
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 ]
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.
Change History Complete list of historical versions of study NCT01393444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Number of Participants Able to 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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
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 ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Tetraplegia
  • Spinal Cord Injury
  • Brachial Plexus Injury
  • Muscular Dystrophy
  • ALS
  • Brainstem Stroke
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Direct Brain Interface Users
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.
Intervention: Device: Implantation of ECoG sensors on the brain surface
Publications * Degenhart AD, Hiremath SV, Yang Y, Foldes S, Collinger JL, Boninger M, Tyler-Kabara EC, Wang W. Remapping cortical modulation for electrocorticographic brain-computer interfaces: a somatotopy-based approach in individuals with upper-limb paralysis. J Neural Eng. 2018 Apr;15(2):026021. doi: 10.1088/1741-2552/aa9bfb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2016)
6
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2011)
3
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01393444
Other Study ID Numbers  ICMJE PRO10010149
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Study sponsors, as well as the FDA, will have access to research data and documents in order to monitor the integrity of the study.
Responsible Party Jennifer Collinger, PhD, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer L Collinger, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP