ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

NCT01393444 | Completed Results DMC

• 1 other identifier: PRO10010149
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG

  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.

  Up to 29 days of device implantation

Secondary Outcomes (1)

• Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System

  Up to 29 days of device implantation

Study Arms (1)

Direct Brain Interface Users

EXPERIMENTAL

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

Interventions

Implantation of ECoG sensors on the brain surface DEVICE

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

Also known as: brain-computer interface, neuroprosthetic

Direct Brain Interface Users

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Certain implanted devices
• Presence of other serious disease or disorder that could affect ability to participate in this study

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 29160240 DERIVED

Related Links

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

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries; Muscular Dystrophies; Brain Stem Infarctions

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Jennifer Collinger
• Organization: University of Pittsburgh

collingr@pitt.edu

412-383-1274

Study Officials

• Jennifer L Collinger, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 13, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)