Spinal Cord Injury (Quadraplegia)NCT01997125
Reanimation in Tetraplegia
A study testing Neural Bridge System in people with Spinal Cord Injury (Quadraplegia), run by Marcia Bockbrader at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Spinal Cord Injury (Quadraplegia)
- What is being tested?
- Neural Bridge System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 13 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center - Center for Neuromodulation
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury (Quadraplegia)
- Being tested
- Neural Bridge System
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Bridge SystemDevice
Also called Blackrock Microsystems Neuroport, Neuromuscular Stimulator
Implanted device
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Neural bridge system implant and external stimulator Receives: Device: Neural Bridge System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury (Quadraplegia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcia Bockbrader
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcia Bockbrader, Ohio State University
- Investigators
- Marcia Bockbrader, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997125
- Sponsor's protocol ID
- 2013H0164
- Other IDs
- 2013H0164
- Status last verified
- Aug 2021
- First submitted
- 22 Nov 2013
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 27074513Sharma 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.
PubMed 27658585Friedenberg 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.
PubMed 28268963Friedenberg 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.
PubMed 28827605Colachis 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.
PubMed 29670506Annetta 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.
PubMed 30106673Schwemmer 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.
PubMed 30250141Skomrock 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.
PubMed 30459542Bockbrader 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.
PubMed 30902630Colachis 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.
PubMed 34352736Ganzer 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.
PubMed 32330415Zhang 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.
PubMed 32232087
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia
- ClinicalTrials.gov ID
- NCT01997125
- Acronym / sponsor ID
- 2013H0164
- Conditions
- Spinal Cord Injury (Quadraplegia)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Marcia BockbraderUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Device: Neural Bridge SystemNeural bridge system implant and external stimulator |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Bridge SystemAlso: Blackrock Microsystems Neuroport, Neuromuscular StimulatorImplanted device | Device | Open Label |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27074513Bouton 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 publication: PubMed 27658585Sharma 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 publication: PubMed 28268963Friedenberg 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 publication: PubMed 28827605Friedenberg 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 publication: PubMed 29670506Colachis 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 publication: PubMed 30106673Annetta 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 publication: PubMed 30250141Schwemmer 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 publication: PubMed 30459542Skomrock 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 publication: PubMed 30902630Bockbrader 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.
- Derived from this study: PubMed 34352736Colachis 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.
- Derived from this study: PubMed 32330415Ganzer 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.
- Derived from this study: PubMed 32232087Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Bockbrader, MD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Bridge System in people with Spinal Cord Injury (Quadraplegia), run by Marcia Bockbrader at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Voluntary Movement (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997125, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.