ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Tetraplegia; Spinal Cord Injury; Brachial Plexus Injury; Muscular Dystrophy; ALS; Brainstem Stroke	Device: Implantation of ECoG sensors on the brain surface	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis
Study Start Date :	May 2011
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	April 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.	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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:	Jennifer L Collinger, PhD	University of Pittsburgh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Brain Computer Interface Research at University of Pittsburgh Medical Center (UPMC) / University of Pittsburgh 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Jennifer Collinger, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01393444 History of Changes
Other Study ID Numbers:	PRO10010149
First Posted:	July 13, 2011
Results First Posted:	December 12, 2016
Last Update Posted:	December 12, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Jennifer Collinger, PhD, 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:

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