Spinal Cord Injury at C4-C6 Level Clinical Trial
Official title:
High Definition Neuromuscular Stimulation in Tetraplegia
| NCT number | NCT04075812 |
| Other study ID # | 2013H0092 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 25, 2013 |
| Est. completion date | June 21, 2019 |
| Verified date | August 2021 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | June 21, 2019 |
| Est. primary completion date | June 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: - Must be 21 years or older. - Must be tetraplegic (C4-6 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. Exclusion Criteria: - No active wound healing or skin breakdown issues. - No history of poorly controlled autonomic dysreflexia. - Other implantable devices such as heart/brain pacemakers - Subjects who rely on ventilators |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University Wexner Medical Center - Center for Neuromodulation | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University |
United States,
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 Co — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Voluntary Movement | consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used.
The participant(s) started out with paralysis due to spinal cord injury, so any active voluntary movement consists of a qualitative change in movement. |
through study completion, up to 60 months | |
| Secondary | Change in Functional Movement | consistent movement in the targeted muscle groups that is functional (manipulate or pick up an object); as assessed by investigator(s) for task completion- no formal scale used Objects were taken from the Action Research Arm Task, Grasp and Release Task, GRASSP as well as using household objects (phone, cup, spoon) | through study completion, up to 60 months |