Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ES2-CHN-2013(SH) | Other Grant/Funding Number | CDRF |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.
We will enroll 4 research participants who have sustained a motor complete SCI to participate in the proposed experiments. Participants will be screened for eligibility, followed by 80 days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80 days of stand epidural stimulation training. These interventions are done in sequential order, however they are cumulative. In between each intervention, participants will undergo motor and cardiovascular experiments and assessments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Stimulation | Experimental | 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-6-5 Specify electrode | Device |
| ||
| Restore Advance Pulse Generator |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Blood Pressure in Response to Epidural Stimulation | Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure. | 20 months |
Not provided
Not provided
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan J Harkema, PhD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29867586 | Background | Aslan SC, Legg Ditterline BE, Park MC, Angeli CA, Rejc E, Chen Y, Ovechkin AV, Krassioukov A, Harkema SJ. Epidural Spinal Cord Stimulation of Lumbosacral Networks Modulates Arterial Blood Pressure in Individuals With Spinal Cord Injury-Induced Cardiovascular Deficits. Front Physiol. 2018 May 18;9:565. doi: 10.3389/fphys.2018.00565. eCollection 2018. | |
| 29020054 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Epidural Stimulation | 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Stimulation | 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Blood Pressure in Response to Epidural Stimulation | Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure. | Posted | Mean | Standard Deviation | mmHg | 20 months |
|
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural Stimulation | 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator *Each participant received all of the interventions. Thus, adverse events cannot be reported for each independent intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision Dehiscence | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Knee Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Harkema | University of Louisville | 502-581-8675 | susan.harkema@louisville.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 27, 2017 | Mar 2, 2022 | Prot_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| Mesbah S, Angeli CA, Keynton RS, El-Baz A, Harkema SJ. A novel approach for automatic visualization and activation detection of evoked potentials induced by epidural spinal cord stimulation in individuals with spinal cord injury. PLoS One. 2017 Oct 11;12(10):e0185582. doi: 10.1371/journal.pone.0185582. eCollection 2017. |
| 30242310 | Result | Harkema SJ, Legg Ditterline B, Wang S, Aslan S, Angeli CA, Ovechkin A, Hirsch GA. Epidural Spinal Cord Stimulation Training and Sustained Recovery of Cardiovascular Function in Individuals With Chronic Cervical Spinal Cord Injury. JAMA Neurol. 2018 Dec 1;75(12):1569-1571. doi: 10.1001/jamaneurol.2018.2617. |
| 29568266 | Result | Harkema SJ, Wang S, Angeli CA, Chen Y, Boakye M, Ugiliweneza B, Hirsch GA. Normalization of Blood Pressure With Spinal Cord Epidural Stimulation After Severe Spinal Cord Injury. Front Hum Neurosci. 2018 Mar 8;12:83. doi: 10.3389/fnhum.2018.00083. eCollection 2018. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| 1 |
| 5 |
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Shoulder Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D014947 | Wounds and Injuries |