Can zapping the spine fix blood pressure after paralysis?

NCT ID NCT06841198

Knowledge-focused Sponsor: Kessler Foundation Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study looks at how blood pressure changes in the first year after a spinal cord injury and whether a device that stimulates the spine through the skin can help. Five people with recent injuries will be followed for a year, testing the stimulation during sessions to see if it raises blood pressure. The goal is to understand if early stimulation is safe and effective for managing low blood pressure.

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 stimulation device (Neostim-5)
What this could lead to: If successful, this could point toward a non-invasive way to manage blood pressure problems after spinal cord injury.
What could go wrong: This is a very small, early-phase study with only 5 participants, so results may not apply to everyone. The stimulation may not consistently raise blood pressure or prevent dizziness.

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 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Nov 2026

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 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

For the main study: Inclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Hypotension, Orthostatic orthostatic hypotension Shy-Drager Syndrome spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular Orthostatic hypotension, dysautonomic Spinal cord injuries (SCI) Transcutaneous spinal stimulation

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.

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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.

Can zapping the spine fix blood pressure after paralysis?

What the study statuses mean