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The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure.
The main questions are:
How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year?
The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.
This clinical study investigates the cardiovascular effects of spinal cord transcutaneous stimulation (scTS) in individuals with recent spinal cord injury (SCI), examining how blood pressure response to stimulation evolves over the first year post-injury. The primary objectives are to determine the optimal timing for initiating scTS for cardiovascular control, characterize blood pressure response evolution to stimulation over one year, and assess autonomic activation patterns through multiple testing methods.
The study will recruit five individuals with recent SCI, specifically targeting those who are 50 days or less post-injury, with an injury level at or above T6, and classified as American Spinal Injury Association Impairment Scale (AIS) A/B. All participants must present with low blood pressure and orthostatic hypotension and be between 18-75 years of age.
The study protocol is divided into inpatient and outpatient phases. During the inpatient phase, consisting of 5-11 sessions, participants undergo a basic assessment including autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor testing, and tilt tests with and without stimulation. The protocol also includes 2-3 days of stimulation mapping.
The outpatient phase spans 15-18 sessions over the remainder of the year. Participants undergo monthly mapping sessions and autonomic dysfunction assessments, with comprehensive autonomic testing conducted at 6, 9, and 12 months post-injury. Throughout both phases, researchers perform stimulation mapping across various spinal segments (thoracic, lumbosacral) using a 5-channel electrical stimulator, while monitoring blood pressure and electromyography to target a blood pressure range of 110-120 mmHg.
The study employs multiple assessment tools, including 70° tilt tests with orthostatic symptom evaluation every 5 minutes, cold pressor tests, autonomic dysfunction questionnaires, and 24-hour ambulatory blood pressure monitoring.
The study aims to track primary outcomes including blood pressure response to stimulation at different time points, evolution of orthostatic hypotension symptoms and management, and the pattern of autonomic dysfunction development post-injury.
A spin-off study is conducted to determine which cold-pressor intervention yields the most stable and consistent blood pressure response. This supplementary study compares 5 individuals with chronic SCI and 5 able-bodied controls. The findings from this spin-off study will directly inform the intervention protocol used in the main study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing position and cooling modality for the ice test | Other | As a spin-off of the main study, we aim to determine which cooling modality and body position elicit the most consistent and stable blood pressure response. To do so, we conduct a supplementary experiment involving 5 individuals with chronic SCI and 5 able-bodied controls. Each participant completes two experimental sessions: one in the supine position and one in the seated position. Within each session, participants undergo two tests, separated by a 30-minute rest period:
The order of body position and cooling modality is pseudo-randomized. Throughout each test, blood pressure is continuously recorded, and participants rate discomfort or pain at 1-minute intervals. |
|
| Main study: assessing the BP changes throughout the first year post SCI | Other | The main study recruits 5 individuals with sub-acute SCI and follows them for one year to evaluate how blood pressure responses evolve during the early post-injury period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal cord transcutaneous stimulation | Device | Stimulation, using the Neostim-5 (Cosyma Ltd.), a 5-channel electrical stimulator, will be administered throughout the study period, beginning shortly after the injury and continuing at regular intervals until one year post-spinal cord injury. It will be performed in two settings:
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure in seated mapping sessions | Spatiotemporal mapping sessions involving stimulation of various spinal segments, utilizing different parameters (e.g., frequency, waveform). A BP response in a mapping session will be defined by a significant increase in SBP of at least 20 mmHg with stimulation compared to baseline SBP (without stimulation) | The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month. |
| systolic blood pressure in a 70 degree tilt | In this study, tilt-tests are conducted in pairs: first, a standard tilt test (without stimulation), followed by a tilt test with stimulation aimed at preventing orthostatic hypotension. We will compare the drop in systolic blood pressure during the tilt test with stimulation to the drop observed in the standard tilt test. | The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months |
| Measure | Description | Time Frame |
|---|---|---|
| cold pressor test | In a traditional cold pressor test, the foot is immersed in 0°C ice water, indirectly assessing the degree of sympathetic activation through BP and HR | The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months |
| 24-hour ambulatory blood pressure monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure changes during ice testing (spin-off experiment) | Change in systolic blood pressure during ice water immersion/ice wrapping, compared to baseline | From enrollment to the end of the second session at 1 month |
| Pain response to ice testing (spin-off experiment) |
For the main study:
Inclusion Criteria:
Exclusion Criteria:
For the spin-off study ice-water vs ice-wrap test (see description in study arms):
____________________________________________________
Inclusion:
Age 18-75.
Inclusion for individuals with SCI:
Exclusion:
Foot lesions, uses a ventilator, devices such as brain/spine/nerve stimulators, significant or recent cardiovascular disease, known infection in the body
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leighann Martinez, BA | Contact | (973)324-3557 | lmartinez@kesslerfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Einat Engel-Haber, MD | Kessler Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39391052 | Background | Engel-Haber E, Bheemreddy A, Bayram MB, Ravi M, Zhang F, Su H, Kirshblum S, Forrest GF. Neuromodulation in Spinal Cord Injury Using Transcutaneous Spinal Stimulation-Mapping for a Blood Pressure Response: A Case Series. Neurotrauma Rep. 2024 Sep 20;5(1):845-856. doi: 10.1089/neur.2024.0066. eCollection 2024. |
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All human subject SCI data will be de-identified. Data shared via a public repository will include demographics (sex, age), injury characteristics (etiology, level and severity of injury), BP measures (systolic, diastolic and heart rate) from mapping, tilt, and 24-hr monitoring data, tilt data (angle, duration, orthostatic questionnaire scores), stimulation data (segment, frequency, amplitude, etc.), responses from the ADF-SCI questionnaire.
Upon completing the data collection, the data will be deposited into a public repository for SCI data
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|
| Ice testing | Procedure | Ice testing is performed using either a 3-minute ice-water immersion or a 3-minute ice-wrap application surrounding the foot. Each participant undergoes both the ice-water and ice-wrap conditions within the same session, separated by a 30-minute interval to allow the foot to return to baseline. Testing is conducted in both the seated and supine positions across two separate sessions, with both the cooling modality and body position randomized. |
|
Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities, and their time points. |
| The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month. |
| An autonomic dysfunction following spinal cord injury questionnaire | Assessing the severity and frequency of daily AD and OH episodes and their effect on daily activities | The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month. |
VAS (Visual Analog Scale) pain ratings (a scale of 0 - no pain to 10 - worst pain) are collected every minute throughout the 3-minute ice test to quantify the pain response associated with each testing modality. |
| From enrollment to the end of the second session at 1 month |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D012791 | Shy-Drager Syndrome |
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019578 | Multiple System Atrophy |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D009069 | Movement Disorders |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054971 | Orthostatic Intolerance |
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