Clinical trial NCT01393444: ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
Official title: Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetraplegia
Spinal Cord Injury
Brachial Plexus Injury
Muscular Dystrophy
ALS
Brainstem Stroke
Keywords: Electrocorticography
Tetraplegia
Spinal cord injury
Brainstem stroke
Neuroprosthetic
Brain-computer interface
Direct brain interface
Neural activity
Motor cortex
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG
timeFrame: Up to 29 days of device implantation
Secondary outcomes:
measure: Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System
timeFrame: Up to 29 days of device implantation
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jennifer L Collinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.