Spinal Cord Injury (Quadraplegia) Clinical Trial
Official title:
Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia
| Verified date | August 2021 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | June 13, 2019 |
| Est. primary completion date | June 13, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 89 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University Wexner Medical Center - Center for Neuromodulation | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Marcia Bockbrader |
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-Compute — 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 — 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 — 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. A — 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: — 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/s415 — 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 — 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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |