Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IK1RX003706 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase seated blood pressure. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without Stimulation | No Intervention | Seated blood pressure without transcutaneous spinal cord stimulation will be assessed. | |
| With Stimulation | Active Comparator | Seated blood pressure with transcutaneous spinal cord stimulation will be assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS8R | Device | transcutaneous stimulation of the spinal cord. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seated Systolic Blood Pressure | Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg. | From enrollment to the end of the last study visit, approximately 30 days. |
Not provided
Not provided
Inclusion Criteria:
above the age of 18 years old
individuals with traumatic spinal cord injuries at or above T6
able to provide consent
non-ventilator
hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caitlyn Peters, PhD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468-3904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38156073 | Derived | Peters CG, Harel NY, Weir JP, Wu YK, Murray LM, Chavez J, Fox FE, Cardozo CP, Wecht JM. Transcutaneous Spinal Cord Stimulation to Stabilize Seated Systolic Blood Pressure in Persons With Chronic Spinal Cord Injury: Protocol Development. Neurotrauma Rep. 2023 Dec 19;4(1):838-847. doi: 10.1089/neur.2023.0063. eCollection 2023. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
10 potential participants were screened and enrolled between June 2022 and December 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | People With Spinal Cord Injury | People with chronic spinal cord injury undergoing spinal cord stimulation to increase and stabilize seated systolic blood pressure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Spinal Cord Stimulation to Increase and Stabilize Systolic Blood Pressure | Demographic, ethnic and spinal cord injury-specific characteristics of the participants enrolled in the trial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Seated Systolic Blood Pressure | Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg. | Posted | Mean | Standard Deviation | mmHg | From enrollment to the end of the last study visit, approximately 30 days. |
|
From enrollment until end of last study visit, up to 30 days.
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 | Stimulation | Participant will have seated blood pressure monitored without and with transcutaneous stimulation. DS8R: transcutaneous stimulation of the spinal cord. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial skin burn | Skin and subcutaneous tissue disorders | Systematic Assessment | Superficial redness and irritation of the skin under the stimulating electrode. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Maria Wecht | James J Peters VA Medical Center | (718) 584-9000 | 3122 | JM.Wecht@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2025 | Aug 28, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2025 | Aug 28, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2023 | Sep 10, 2024 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007024 | Hypotension, Orthostatic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
All participants will complete transcutaneous stimulation mapping sessions to determine the optimal parameters to increase and maintain systolic blood pressure between 110-130 mmHg.
Not provided
Not provided
Participants will be blinded to which stimulation parameters they are receiving.
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Neurological level of spinal cord injury | This was determined using the International Standards for Neurological Classification of Spinal Cord Injury exam (Kirshblum et al., 2011). | Count of Participants | Participants |
|
| AIS classification of injury | American Spinal Injury Association Impairment Scale (AIS) classification is determined with the International Standards for Neurological Classification of Spinal Cord Injury exam (Kirshblum et al., 2011). AIS A - no sensory or motor function below the neurological level of spinal cord injury; AIS B - sensory, but no motor function preserved below the neurological level of spinal cord injury; AIS C - sensory and partial motor function preserved below the neurological level of spinal cord injury. | Count of Participants | Participants |
|
| Time since injury | Mean | Standard Deviation | years |
|
Seated blood pressure assessed with TSCS at T9/10. |
| OG003 | T11/12 | Seated blood pressure assessed with TSCS at T11/12. |
| OG004 | L1/2 | Seated blood pressure assessed with TSCS at L1/2. |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
|
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |