Spinal stimulation may tame blood pressure swings after injury
NCT ID NCT05305118
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether transcutaneous spinal cord stimulation (TSCS) can help stabilize blood pressure in people recently hospitalized with a spinal cord injury. After such injuries, blood pressure often swings between dangerously low and high levels, which can interfere with rehabilitation. The study will map stimulation settings and measure blood pressure and heart rate responses during sit-up tests, with and without stimulation, to see if TSCS is safe and feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcutaneous spinal cord stimulation (TSCS) - a non-invasive procedure using electrodes on the back to deliver electrical pulses.
- What this could lead to
- If effective, TSCS could offer a non-drug way to stabilize blood pressure during rehabilitation, potentially improving recovery and reducing complications.
- What could go wrong
- This is an early feasibility study with a small number of participants. The optimal stimulation parameters are still being mapped, and individual responses may vary. Risks include discomfort or skin irritation from the electrodes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2022
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 89 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * All newly injured patients with SCI who are sequentially admitted during the 42-month recruitment period * Meet the following Model Systems entry criteria with evidence of BP instability * Exhibit one or more of the following: Resting hypotension - systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females; OH - fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position; BP instability - fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg within a single day during routine activities in the AIR setting. * Have trouble with your blood pressure as determined by your doctor. * Participants must be between the ages of 18-89 years old, experienced a spinal cord injury (SCI) within the past 30 days to 6 months, have sustained a SCI with temporary or permanent loss of sensory and/or motor function, and are an inpatient for acute SCI rehabilitation therapy at Mount Sinai. * You are not dependent on a ventilator at this time. * You do not have a history of implanted pacemaker/defibrillator or significant coronary artery disease. Exclusion Criteria: * Implanted brain/spine/nerve stimulators, cochlear implants, cardiac pacemaker/defibrillator, or intracardiac lines * Open skin lesions on or near the electrode placement sites (neck, upper back) * Significant coronary artery or cardiac conduction disease * Recent history of myocardial infarction * Insufficient mental capacity to understand and independently provide consent * Pregnancy * Cancer * Deemed unsuitable by study physician As part of the feasibility assessment, the study team will document demographic and injury characteristics of eligible patients who refuse enrollment, as well as reasons for ineligibility among those who do not meet entrance criteria.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute spinal cord injury are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Mount Sinai Spinal Cord Injury Model System
RECRUITINGNew York, New York, 10029, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can classroom workouts make a generation healthier?
- Can a diabetes drug shield aging blood vessels?
- Blood pressure monitoring without needles: a new algorithm under test
- Can a slower oxytocin infusion prevent dangerous blood pressure drops in C-Sections?
- Cuffless blood pressure: a tiny chest patch put to the test
- Can a smart pump prevent dangerous drops in blood pressure during C-Sections?