Spinal Cord Injuries (SCI)NCT06841198
Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
A study testing spinal cord transcutaneous stimulation and Ice testing in people with Spinal Cord Injuries (SCI) and Orthostatic Hypotension, Dysautonomic, run by Kessler Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries (SCI), Orthostatic Hypotension, Dysautonomic, Cardiovascular
- What is being tested?
- spinal cord transcutaneous stimulation and Ice testing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
- Between 18-75 years old
- 7-50 days after injury
- Injury level ≥ T6 (a cervical or a high-level chest injury)
- Individuals experiencing low blood pressure after the injury
- American Spinal Injury Association Impairment Scale (AIS) A or B
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- Age 18-75.
- Injury sustained more than 6 months ago
- Injury level ≥ T6 (a cervical or a high-level chest injury)
- American spinal injury association impairment scale (AIS) A - D
Who cannot join
- A ventilator is needed for breathing.
- Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
- There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
- A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
- There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
- There is a history of seizures.
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- Pregnancy.
- For the spin-off study ice-water vs ice-wrap test (see description in study arms):
- Foot lesions, uses a ventilator, devices such as brain/spine/nerve stimulators, significant or recent cardiovascular disease, known infection in the body
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries (SCI), Orthostatic Hypotension, Dysautonomic, Cardiovascular, Transcutaneous Spinal Stimulation
- Being tested
- spinal cord transcutaneous stimulation, Ice testing
- Keywords
- Transcutaneous Spinal Cord Stimulation, spinal cord stimulation, orthostatic hypotension, blood pressure, cardiovascular, neuromodulation, acute spinal cord injury, chronic spinal cord injury, inpatient rehabilitation, tilt testing, cold pressor test, ambulatory blood pressure monitoring, autonomic dysfunction following spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Shy-Drager Syndrome, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord transcutaneous stimulationDevice
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:
- During seated mapping to identify stimulation sites (potentially T7/8, T11/12, L1/2, and S1/2) and determine stimulation parameters (e.g., frequency, pulse wave, amplitude) that elevate systolic blood pressure (SBP) and maintain it within the target range of 110-120 mmHg.
- During 70-degree tilt tests to elicit an orthostatic response (a drop in blood pressure accompanied by symptoms).
Ice testingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. an ice-water immersion test, in which the foot is submerged in ice water for 3 minutes, and
2. an ice-wrap test, in which ice packs are applied around the foot and ankle for 3 minutes.
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. Receives: Procedure: Ice testing |
| 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. Receives: Device: spinal cord transcutaneous stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
Secondary outcomes (3)
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
Measured: 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
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.
Measured: 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
Measured: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Apr 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Einat Haber, Kessler Foundation
- Investigators
- Einat Engel-Haber, MD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841198
- Sponsor's protocol ID
- R1287-25
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39391052
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury
- ClinicalTrials.gov ID
- NCT06841198
- Acronym / sponsor ID
- R1287-25
- Conditions
- Spinal Cord Injuries (SCI), Orthostatic Hypotension, Dysautonomic, Cardiovascular, Transcutaneous Spinal Stimulation
- Keywords
- Transcutaneous Spinal Cord Stimulation, spinal cord stimulation, orthostatic hypotension, blood pressure, cardiovascular, neuromodulation, acute spinal cord injury, chronic spinal cord injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing position and cooling modality for the ice test | Other | Procedure: Ice testingAs 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: 1. an ice-water immersion test, in which the foot is submerged in ice water for 3 minutes, and 2. an ice-wrap test, in which ice packs are applied around the foot and ankle for 3 minutes. 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 | Device: spinal cord transcutaneous stimulationThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
- Between 18-75 years old
- 7-50 days after injury
- Injury level ≥ T6 (a cervical or a high-level chest injury)
- Individuals experiencing low blood pressure after the injury
Key exclusion criteria (9 listed)
- A ventilator is needed for breathing.
- Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
- There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
- A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
- There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal cord transcutaneous stimulationStimulation, 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: 1. During seated mapping to identify stimulation sites (potentially T7/8, T11/12, L1/2, and S1/2) and determine stimulation parameters (e.g., frequency, pulse wave, amplitude) that elevate systolic blood pressure (SBP) and maintain it within the target range of 110-120 mmHg. 2. During 70-degree tilt tests to elicit an orthostatic response (a drop in blood pressure accompanied by symptoms). | Device | Main study: assessing the BP changes throughout the first year post SCI |
| Ice testingIce 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. | Procedure or surgery | Testing position and cooling modality for the ice test |
Primary outcome
Systolic blood pressure in seated mapping sessions
Time frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
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)
systolic blood pressure in a 70 degree tilt
Time frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
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.
3 secondary outcomes
cold pressor test
Time frame: 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
Time frame: 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
Time frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 39391052Engel-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Einat Engel-Haber, MD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal cord transcutaneous stimulation and Ice testing in people with Spinal Cord Injuries (SCI) and Orthostatic Hypotension, Dysautonomic, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leighann Martinez, BA ((973)324-3557, lmartinez@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure in seated mapping sessions (time frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06841198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.