NCT01997125

Brief Summary

The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 9, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

5.6 years

First QC Date

November 22, 2013

Results QC Date

August 29, 2019

Last Update Submit

August 5, 2021

Conditions

Spinal Cord Injury (Quadraplegia)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Voluntary Movement

    The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system

    9 months

Study Arms (1)

Open Label

EXPERIMENTAL

Neural bridge system implant and external stimulator

Device: Neural Bridge System

Interventions

Neural Bridge SystemDEVICE

Implanted device

Also known as: Blackrock Microsystems Neuroport, Neuromuscular Stimulator
Open Label

Eligibility Criteria

Age21 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 21 years or older.
  • Must be tetraplegic (C4- C6 ASIA A).
  • months post injury and neurologically stable.
  • Participant is willing to comply with all follow-up evaluations at the specified times.
  • Participant is able to provide informed consent prior to enrollment in the study.
  • The participant is fluent in English.
  • Participant must have a caregiver willing to participate in the study who will provide care for the surgical site.

You may not qualify if:

  • No active wound healing or skin breakdown issues.
  • No history of poorly controlled autonomic dysreflexia.
  • Medical contraindications for general anesthesia, craniotomy, or surgery.
  • Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
  • Participants with any type of destruction and/or damage to the motor cortex region as determined by MRI.
  • History of psychiatric disturbance or dementia
  • Other implantable devices such as heart/brain pacemakers
  • Participants who rely on ventilators
  • Co-morbid conditions that would interfere with study activities or response to treatment.
  • History of a neurological ablation procedure.
  • Labeled contraindication for MRI.
  • History of hemorrhagic stroke.
  • History of HIV infection or ongoing chronic infection (such as tuberculosis).
  • Pregnant or of child-bearing potential and are not taking acceptable methods of contraception.
  • Participation in another FDA device or medication trial that would interfere with the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center - Center for Neuromodulation

Columbus, Ohio, 43210, United States

Location

Related Publications (12)

  • Bouton CE, Shaikhouni A, Annetta NV, Bockbrader MA, Friedenberg DA, Nielson DM, Sharma G, Sederberg PB, Glenn BC, Mysiw WJ, Morgan AG, Deogaonkar M, Rezai AR. Restoring cortical control of functional movement in a human with quadriplegia. Nature. 2016 May 12;533(7602):247-50. doi: 10.1038/nature17435. Epub 2016 Apr 13.

    PMID: 27074513RESULT

  • Sharma G, Friedenberg DA, Annetta N, Glenn B, Bockbrader M, Majstorovic C, Domas S, Mysiw WJ, Rezai A, Bouton C. Using an Artificial Neural Bypass to Restore Cortical Control of Rhythmic Movements in a Human with Quadriplegia. Sci Rep. 2016 Sep 23;6:33807. doi: 10.1038/srep33807.

    PMID: 27658585RESULT

  • Friedenberg DA, Bouton CE, Annetta NV, Skomrock N, Mingming Zhang, Schwemmer M, Bockbrader MA, Mysiw WJ, Rezai AR, Bresler HS, Sharma G. Big data challenges in decoding cortical activity in a human with quadriplegia to inform a brain computer interface. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3084-3087. doi: 10.1109/EMBC.2016.7591381.

    PMID: 28268963RESULT

  • Friedenberg DA, Schwemmer MA, Landgraf AJ, Annetta NV, Bockbrader MA, Bouton CE, Zhang M, Rezai AR, Mysiw WJ, Bresler HS, Sharma G. Neuroprosthetic-enabled control of graded arm muscle contraction in a paralyzed human. Sci Rep. 2017 Aug 21;7(1):8386. doi: 10.1038/s41598-017-08120-9.

    PMID: 28827605RESULT

  • Colachis SC 4th, Bockbrader MA, Zhang M, Friedenberg DA, Annetta NV, Schwemmer MA, Skomrock ND, Mysiw WJ, Rezai AR, Bresler HS, Sharma G. Dexterous Control of Seven Functional Hand Movements Using Cortically-Controlled Transcutaneous Muscle Stimulation in a Person With Tetraplegia. Front Neurosci. 2018 Apr 4;12:208. doi: 10.3389/fnins.2018.00208. eCollection 2018.

    PMID: 29670506RESULT

  • Annetta NV, Friend J, Schimmoeller A, Buck VS, Friedenberg DA, Bouton CE, Bockbrader MA, Ganzer PD, Colachis Iv SC, Zhang M, Mysiw WJ, Rezai AR, Sharma G. A High Definition Noninvasive Neuromuscular Electrical Stimulation System for Cortical Control of Combinatorial Rotary Hand Movements in a Human With Tetraplegia. IEEE Trans Biomed Eng. 2019 Apr;66(4):910-919. doi: 10.1109/TBME.2018.2864104. Epub 2018 Aug 7.

    PMID: 30106673RESULT

  • Schwemmer MA, Skomrock ND, Sederberg PB, Ting JE, Sharma G, Bockbrader MA, Friedenberg DA. Meeting brain-computer interface user performance expectations using a deep neural network decoding framework. Nat Med. 2018 Nov;24(11):1669-1676. doi: 10.1038/s41591-018-0171-y. Epub 2018 Sep 24.

    PMID: 30250141RESULT

  • Skomrock ND, Schwemmer MA, Ting JE, Trivedi HR, Sharma G, Bockbrader MA, Friedenberg DA. A Characterization of Brain-Computer Interface Performance Trade-Offs Using Support Vector Machines and Deep Neural Networks to Decode Movement Intent. Front Neurosci. 2018 Oct 24;12:763. doi: 10.3389/fnins.2018.00763. eCollection 2018.

    PMID: 30459542RESULT

  • Bockbrader M, Annetta N, Friedenberg D, Schwemmer M, Skomrock N, Colachis S 4th, Zhang M, Bouton C, Rezai A, Sharma G, Mysiw WJ. Clinically Significant Gains in Skillful Grasp Coordination by an Individual With Tetraplegia Using an Implanted Brain-Computer Interface With Forearm Transcutaneous Muscle Stimulation. Arch Phys Med Rehabil. 2019 Jul;100(7):1201-1217. doi: 10.1016/j.apmr.2018.07.445. Epub 2019 Mar 20.

    PMID: 30902630RESULT

  • Colachis SC 4th, Dunlap CF, Annetta NV, Tamrakar SM, Bockbrader MA, Friedenberg DA. Long-term intracortical microelectrode array performance in a human: a 5 year retrospective analysis. J Neural Eng. 2021 Aug 23;18(4). doi: 10.1088/1741-2552/ac1add.

    PMID: 34352736DERIVED

  • Ganzer PD, Colachis SC 4th, Schwemmer MA, Friedenberg DA, Dunlap CF, Swiftney CE, Jacobowitz AF, Weber DJ, Bockbrader MA, Sharma G. Restoring the Sense of Touch Using a Sensorimotor Demultiplexing Neural Interface. Cell. 2020 May 14;181(4):763-773.e12. doi: 10.1016/j.cell.2020.03.054. Epub 2020 Apr 23.

    PMID: 32330415DERIVED

  • Zhang M, Schwemmer MA, Ting JE, Majstorovic CE, Friedenberg DA, Bockbrader MA, Jerry Mysiw W, Rezai AR, Annetta NV, Bouton CE, Bresler HS, Sharma G. Extracting wavelet based neural features from human intracortical recordings for neuroprosthetics applications. Bioelectron Med. 2018 Jul 31;4:11. doi: 10.1186/s42234-018-0011-x. eCollection 2018.

    PMID: 32232087DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Marcia Bockbrader MD PhD
Organization
The Ohio State University
bockbrader.13@osu.edu
6142937604

Study Officials

  • Marcia Bockbrader, MD, PhD

    Ohio State University

    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
MD, PhD

Study Record Dates

First Submitted

November 22, 2013

First Posted

November 27, 2013

Study Start

November 1, 2013

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

August 31, 2021

Results First Posted

July 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)