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ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

NCT ID: NCT01393444

Last Updated: 2016-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Tetraplegia Spinal Cord Injury Brachial Plexus Injury Muscular Dystrophy ALS Brainstem Stroke

Keywords

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Electrocorticography Tetraplegia Spinal cord injury Brainstem stroke Neuroprosthetic Brain-computer interface Direct brain interface Neural activity Motor cortex

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Implantation of ECoG sensors on the brain surface

Intervention Type DEVICE

One ECoG sensor will be implanted over the motor cortex of study participants

Interventions

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Implantation of ECoG sensors on the brain surface

One ECoG sensor will be implanted over the motor cortex of study participants

Intervention Type DEVICE

Other Intervention Names

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brain-computer interface neuroprosthetic

Eligibility Criteria

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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)

Exclusion Criteria

* Certain implanted devices
* Presence of other serious disease or disorder that could affect ability to participate in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Collinger, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer L Collinger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29160240 (View on PubMed)

Related Links

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http://www.upmc.com/bci

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

Other Identifiers

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PRO10010149

Identifier Type: -

Identifier Source: org_study_id