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Reanimation in Tetraplegia

Primary Purpose

Spinal Cord Injury (Quadraplegia)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Neural Bridge System

About this trial

This is an interventional other trial for Spinal Cord Injury (Quadraplegia)

Eligibility Criteria

21 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be 21 years or older.
Must be tetraplegic (C4- C6 ASIA A).
12 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.

Exclusion Criteria:

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.

Sites / Locations

The Ohio State University Wexner Medical Center - Center for Neuromodulation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Neural bridge system implant and external stimulator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01997125

First Posted

November 22, 2013

Last Updated

August 5, 2021

Sponsor

Marcia Bockbrader

1. Study Identification

Unique Protocol Identification Number

NCT01997125

Brief Title

Reanimation in Tetraplegia

Official Title

Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

June 13, 2019 (Actual)

Study Completion Date

June 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marcia Bockbrader

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post injury, and who are neurologically stable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury (Quadraplegia)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Label

Arm Type

Experimental

Arm Description

Neural bridge system implant and external stimulator

Intervention Type

Device

Intervention Name(s)

Neural Bridge System

Other Intervention Name(s)

Blackrock Microsystems Neuroport, Neuromuscular Stimulator

Intervention Description

Implanted device

Primary Outcome Measure Information:

Title

Number of Participants With Voluntary Movement

Description

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

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be 21 years or older. Must be tetraplegic (C4- C6 ASIA A). 12 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcia Bockbrader, MD, PhD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University Wexner Medical Center - Center for Neuromodulation

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27074513

Citation

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.

Results Reference

result

PubMed Identifier

27658585

Citation

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.

Results Reference

result

PubMed Identifier

28268963

Citation

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.

Results Reference

result

PubMed Identifier

28827605

Citation

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.

Results Reference

result

PubMed Identifier

29670506

Citation

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.

Results Reference

result

PubMed Identifier

30106673

Citation

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.

Results Reference

result

PubMed Identifier

30250141

Citation

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.

Results Reference

result

PubMed Identifier

30459542

Citation

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.

Results Reference

result

PubMed Identifier

30902630

Citation

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.

Results Reference

result

PubMed Identifier

34352736

Citation

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.

Results Reference

derived

PubMed Identifier

32330415

Citation

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.

Results Reference

derived

PubMed Identifier

32232087

Citation

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.

Results Reference

derived

Links:

URL

http://u.osu.edu/bockbrader.13/neurolife/

Description

Clinical Trial website

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Reanimation in Tetraplegia

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