- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01997125
Reanimation in Tetraplegia
August 5, 2021 updated by: Marcia Bockbrader
Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center - Center for Neuromodulation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 89 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Open Label
Neural bridge system implant and external stimulator
|
Implanted device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Voluntary Movement
Time Frame: 9 months
|
The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcia Bockbrader, MD, PhD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2013
Primary Completion (ACTUAL)
June 13, 2019
Study Completion (ACTUAL)
June 13, 2019
Study Registration Dates
First Submitted
November 22, 2013
First Submitted That Met QC Criteria
November 22, 2013
First Posted (ESTIMATE)
November 27, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 31, 2021
Last Update Submitted That Met QC Criteria
August 5, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013H0164 (OTHER: Ohio State University Biomedical IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury (Quadraplegia)
-
University of ManitobaThe Association of Rehabilitation Medicine in ManitobaCompletedSpinal Cord Injury | Tetraplegia | Quadraplegia | Low HDL-c | High LDL-cCanada
-
Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
-
Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
-
NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
-
S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
-
Mahidol UniversityRecruitingSpinal Cord Injury | Incomplete Spinal Cord InjuryThailand
Clinical Trials on Neural Bridge System
-
Jacques E. ChellyNational Institute on Drug Abuse (NIDA); Masimo CorporationRecruitingOpioid Use | Cancer Pain | Auriculotherapy | Pain, AbdominalUnited States
-
Cairo UniversityNot yet recruitingEvaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System
-
Centre Hospitalier Universitaire, AmiensCentre Hospitalier de BeauvaisActive, not recruiting
-
Leigh R. Hochberg, MD, PhD.National Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingAmyotrophic Lateral Sclerosis | Muscular Dystrophies | Spinal Cord Injuries | Tetraplegia | Dysarthria | Brain Stem Infarctions | Locked-in Syndrome | AnarthriaUnited States
-
Leigh R. Hochberg, MD, PhD.National Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingAmyotrophic Lateral Sclerosis | Muscular Dystrophies | Spinal Cord Injuries | Tetraplegia | Dysarthria | Brain Stem Infarctions | Locked in Syndrome | AnarthriaUnited States
-
Chad BoutonRecruitingSpinal Cord Injuries | Spinal Cord Injury CervicalUnited States
-
MicroPort NeuroTech Co., Ltd.RecruitingBrain Diseases | Vertebral Artery Stenosis | Vertebral Artery ThrombosisChina
-
Jacques E. ChellyCompletedSurgery | Acute Pain | Abdominal CancerUnited States
-
Medical College of WisconsinCompletedCyclic Vomiting Syndrome | Abdominal MigraineUnited States
-
Josue Fernandez CarneroUniversidad Autonoma de MadridCompleted