Spinal stimulation may steady blood pressure in paralyzed patients

NCT ID NCT07504055

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a non-invasive spinal cord stimulation can improve blood pressure control in people with chronic spinal cord injury. Researchers will place electrodes on the skin over the spinal cord and stimulate different sites to see which works best. The goal is to help prevent dangerous blood pressure swings, like drops or spikes, that can occur after spinal cord injury. The study involves 40 adults with motor-complete spinal cord injury above the T1 level.

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 40 people

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

Started

Apr 2026

Expected to finish

Feb 2029

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 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least 18 years old, * Stable medical condition, * Non-progression SCI (no negative change in the neurological level and motor-completeness assess during screening when compared to the neurological status assessed at 6-month period after injury or at least 6 months prior to the screening), * Motor-complete SCI according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade "A," "B," or "C" above T1 spinal level according to the ASIA International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury (NLI), * Sustained SCI at least 12 months prior to entering the study, * Evidence of symptomatic hypotension as determined by a total score \>0 on the Orthostatic Hypotension Symptom Assessment (OSHA), * Normal renal function as defined by eGFR \> 59 ml/min/1.73, creatinine value within the range of 0.6-1.2 mg/dl, and BUN values within the range of 7-18 mg/dl, * Competent to give informed consent for the research protocol, * Able to understand instructions. Exclusion Criteria: * Major pulmonary or cardiovascular disease unrelated to SCI, * Ventilator dependence, * Painful musculoskeletal dysfunction that might interfere with testing or stimulation, * Unhealed fracture that might interfere with testing or stimulation, * Unhealed contracture that might interfere with testing or stimulation, * Unhealed pressure sore that might interfere with testing or stimulation, * Untreated clinically significant depression or psychiatric disorders, * Ongoing drug abuse, * Malignancy , * Class III obesity (BMI \>40) and at least one co-morbidity thereof: a) Type 2 diabetes as defined by ≥6.5% level on two separate glycated hemoglobin (A1C) tests, b) hypertension as defined by consistent blood pressure readings of ≥140/90 mmHg or taking medication for blood pressure, * Acute or chronic obstructive deep vein thrombosis, * Secondary hypotension unrelated to SCI (anemia, hypervolemia, endocrine and neurological diseases), * Major esophageal/gastrointestinal problem, * Currently pregnant (females of childbearing potential only), * Other major medical illness contraindicated for testing or stimulation.

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Frazier Rehabilitation Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Frazier Rehabilitation and Neuroscience Institute

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

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