Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Minnesota Office of Higher Education | OTHER_GOV |
| Hennepin Healthcare Research Institute | OTHER |
| Hennepin County Medical Center, Minneapolis | OTHER |
Not provided
Not provided
Not provided
Not provided
This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.
Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability.
In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Spinal Cord Stimulation | Experimental | Epidural Spinal Cord Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Spinal Cord Stimulation | Device | epidural spinal cord stimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Volitional Response Index Magnitude | Brain Motor Control Assessment Volitional Response Index Magnitude | Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal cord stimulation for cardiovascular function | Systolic blood pressure measured during epidural stimulation (continuous) | Over 12 months |
| Cerebrovascular Assessment Change | Cerebral blood flow (CBF) during tilt table |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 612-873-9113 | estand@umn.edu | |
| David Darrow, MD MPH | Contact | 612-217-4290 | estand@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Darrow, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Recruiting | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37179555 | Derived | Shackleton C, Samejima S, Miller T, Sachdeva R, Parr A, Samadani U, Netoff T, Hocaloski S, Elliott S, Walter M, Darrow D, Krassioukov A. Effect of epidural spinal cord stimulation on female sexual function after spinal cord injury. Front Neurosci. 2023 Apr 5;17:1155796. doi: 10.3389/fnins.2023.1155796. eCollection 2023. | |
| 36719784 |
| Label | URL |
|---|---|
| Clinical Trial Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.
Not provided
Not provided
Masking is done during formal testing of BMCA
Not provided
| Months: 3, 6, 9 |
| Change in Visual Neurocognitive Assessment | Stroop Test | Months: 3, 6, 9 |
| Spinal cord stimulation optimization | Probit preference response surface obtained by serial force binary choice | Over 12 months |
| Hoover C, Schuerger W, Balser D, McCracken P, Murray TA, Morse L, Parr A, Samadani U, Netoff TI, Darrow DP. Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. J Neurotrauma. 2024 May;41(9-10):1163-1171. doi: 10.1089/neu.2022.0322. Epub 2023 Mar 22. |
| 36517395 | Derived | Hoglund BK, Zurn CA, Madden LR, Hoover C, Slopsema JP, Balser D, Parr A, Samadani U, Johnson MD, Netoff TI, Darrow DP. Mapping Spinal Cord Stimulation-Evoked Muscle Responses in Patients With Chronic Spinal Cord Injury. Neuromodulation. 2023 Oct;26(7):1371-1380. doi: 10.1016/j.neurom.2022.10.058. Epub 2022 Dec 12. |
| 35851008 | Derived | Darrow DP, Balser DY, Freeman D, Pelrine E, Krassioukov A, Phillips A, Netoff T, Parr A, Samadani U. Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial. BMJ Open. 2022 Jul 18;12(7):e059126. doi: 10.1136/bmjopen-2021-059126. |
| 32714156 | Derived | Pena Pino I, Hoover C, Venkatesh S, Ahmadi A, Sturtevant D, Patrick N, Freeman D, Parr A, Samadani U, Balser D, Krassioukov A, Phillips A, Netoff TI, Darrow D. Long-Term Spinal Cord Stimulation After Chronic Complete Spinal Cord Injury Enables Volitional Movement in the Absence of Stimulation. Front Syst Neurosci. 2020 Jun 30;14:35. doi: 10.3389/fnsys.2020.00035. eCollection 2020. |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |