Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

NCT01364480 | Terminated Results DMC

• 1 other identifier: STUDY19030235
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.

Conditions

Tetraplegia; Spinal Cord Injury

Keywords

Tetraplegia; Spinal cord injury; Brainstem or spinal stroke; Neuroprosthetic; Brain-machine interface; Brain-computer interface; Neural activity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Implant

  Number of participants who were implanted for at least one year without having to explant the device for safety reasons.

  One year following array implantation

Secondary Outcomes (2)

• 7 Degree-of-freedom Movement by Neural Control

  One year following array implantation

• 10 Degree-of-freedom Movement by Neural Control

  One year following array implantation

Study Arms (1)

Brain-Machine Interface Users

EXPERIMENTAL

All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.

Device: Implantation of NeuroPort Arrays in the motor cortex

Interventions

Implantation of NeuroPort Arrays in the motor cortex DEVICE

Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.

Also known as: neuroprosthetic, brain-machine interface, brain-computer interface

Brain-Machine 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 or brainstem or spinal stroke
• At least 1 year post-injury
• Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training

You may not qualify if:

• Certain implanted devices
• Presence of other serious disease or disorder that could affect ability to participate in this study
• Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise

Sponsors & Collaborators

• Michael Boninger: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• Sponheim C, Papadourakis V, Collinger JL, Downey J, Weiss J, Pentousi L, Elliott K, Hatsopoulos NG. Longevity and reliability of chronic unit recordings using the Utah, intracortical multi-electrode arrays. J Neural Eng. 2021 Dec 28;18(6):10.1088/1741-2552/ac3eaf. doi: 10.1088/1741-2552/ac3eaf.

  PMID: 34847547 DERIVED

• Downey JE, Quick KM, Schwed N, Weiss JM, Wittenberg GF, Boninger ML, Collinger JL. The Motor Cortex Has Independent Representations for Ipsilateral and Contralateral Arm Movements But Correlated Representations for Grasping. Cereb Cortex. 2020 Sep 3;30(10):5400-5409. doi: 10.1093/cercor/bhaa120.

  PMID: 32494819 DERIVED

• Downey JE, Schwed N, Chase SM, Schwartz AB, Collinger JL. Intracortical recording stability in human brain-computer interface users. J Neural Eng. 2018 Aug;15(4):046016. doi: 10.1088/1741-2552/aab7a0. Epub 2018 Mar 19.

  PMID: 29553484 DERIVED

• Downey JE, Brane L, Gaunt RA, Tyler-Kabara EC, Boninger ML, Collinger JL. Motor cortical activity changes during neuroprosthetic-controlled object interaction. Sci Rep. 2017 Dec 5;7(1):16947. doi: 10.1038/s41598-017-17222-3.

  PMID: 29209023 DERIVED

• Downey JE, Weiss JM, Muelling K, Venkatraman A, Valois JS, Hebert M, Bagnell JA, Schwartz AB, Collinger JL. Blending of brain-machine interface and vision-guided autonomous robotics improves neuroprosthetic arm performance during grasping. J Neuroeng Rehabil. 2016 Mar 18;13:28. doi: 10.1186/s12984-016-0134-9.

  PMID: 26987662 DERIVED

• Wodlinger B, Downey JE, Tyler-Kabara EC, Schwartz AB, Boninger ML, Collinger JL. Ten-dimensional anthropomorphic arm control in a human brain-machine interface: difficulties, solutions, and limitations. J Neural Eng. 2015 Feb;12(1):016011. doi: 10.1088/1741-2560/12/1/016011. Epub 2014 Dec 16.

  PMID: 25514320 DERIVED

• Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. doi: 10.1016/S0140-6736(12)61816-9. Epub 2012 Dec 17.

  PMID: 23253623 DERIVED

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Debbie Harrington, CCRP, senior research coordinator
• Organization: University of Pittsburgh

debbie.harrington@pitt.edu

4123831355

Study Officials

• Michael L Boninger, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair of Research

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: June 2, 2011
• Study Start: May 1, 2011
• Primary Completion: November 26, 2022
• Study Completion: November 26, 2022
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Minimum of seven years after final reporting or publication
• Access Criteria: Researchers interested in this topic at the University of Pittsburgh, the University of Chicago, and other centers

Locations

US (1)