ClinicalTrials.gov record NCT06841198
Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study follows people early after spinal cord injury for one year to track blood pressure and autonomic function while using transcutaneous spinal stimulation. Participants start during an inpatient stay and continue as outpatients, totaling about 20–29 sessions over the year. The study uses mapping sessions, tilt tests (with and without stimulation), cold‑stress tests, and 24‑hour blood pressure monitoring.
What it is studying. The study is testing when and how transcutaneous spinal cord stimulation (scTS) should be started after injury to influence blood pressure control. It aims to describe how blood pressure responses and autonomic activation change across the first year after spinal cord injury and how stimulation affects those responses at different times.
What the researchers hope to learn. Determine the best timing to start transcutaneous spinal stimulation after SCI for affecting blood pressure control; characterize how blood pressure response to stimulation evolves over the first year; map autonomic activation patterns using tilt tests, cold‑stress tests, ambulatory blood pressure monitoring, and stimulation mapping; identify which cold‑pressor method gives the most consistent blood pressure response for use in testing.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Procedure
- Ice testing
- Device
- spinal cord transcutaneous stimulation
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- For the main study:
- 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
Exclusion criteria
- 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.
- Pregnancy.
- 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:
- 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
- Exclusion:
- Foot lesions, uses a ventilator, devices such as brain/spine/nerve stimulators, significant or recent cardiovascular disease, known infection in the body
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participation starts during an inpatient period and continues for about one year with roughly 20–29 sessions total (about 5–11 inpatient visits and 15–18 outpatient visits). Visits include questionnaires about autonomic symptoms, 24‑hour ambulatory blood pressure monitoring, cold pressor (ice) tests, 70° tilt‑table tests done with and without transcutaneous (through‑the‑skin) spinal stimulation, and repeated stimulation mapping to find settings that raise systolic blood pressure to a target range. Mapping uses a 5‑channel surface electrical stimulator while blood pressure and muscle activity are recorded; ice tests (3 minutes) and tilt tests may cause discomfort and you will be asked to rate symptoms. A small separate experiment compares ice‑water versus ice‑wrap foot tests in chronic SCI and able‑bodied volunteers.
How the study is structured. A small, single-group interventional study with no masking. Five people with recent SCI receive repeated transcutaneous spinal stimulation mapping sessions (seated) and stimulation during 70° tilt tests across the first year after injury. Monthly and quarterly testing includes 24‑hour ambulatory blood pressure monitoring, cold pressor tests, autonomic questionnaires, and paired tilt tests performed with and without stimulation. A separate spin-off experiment compares two cold‑stressor methods (ice‑water immersion vs ice‑wrap) in 5 people with chronic SCI and 5 able-bodied controls; each of those participants completes seated and supine sessions with randomized order.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Spinal Cord Injuries (SCI); Orthostatic Hypotension, Dysautonomic; Cardiovascular; Transcutaneous Spinal Stimulation. Does it apply to my diagnosis?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Apr 1, 2025
- Primary completion
- November 2026 (estimated)
- Study completion
- November 2026 (estimated)
- Target enrollment
- 15 participants (estimated)
- Last updated on registry
- Jul 1, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Kessler Foundation
- Principal investigator
- Einat Haber, Associate Research Scientist
Kessler Foundation
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Leighann Martinez, BA 📞 (973)324-3557 ✉ lmartinez@kesslerfoundation.org
Participating sites (1)
- Kessler FoundationRecruiting
West Orange, New Jersey, 07052 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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