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Spinal zap plus breathing drills may boost lung power after paralysis

NCT ID NCT06019949

Symptom relief Sponsor: University of Louisville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
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This status has not been confirmed recently, so it may be out of date.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 whether a gentle electrical stimulation of the spinal cord, combined with breathing exercises, can improve lung function in people with chronic spinal cord injury. About 36 adults will be split into three groups: breathing training alone, stimulation alone, or both together. The goal is to see if the combination leads to stronger breathing muscles and better lung health.

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 36 people

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

Started

Sep 2023

Expected to finish

Apr 2030

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; * no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation; * no clinically significant depression, psychiatric disorders or ongoing drug abuse; * non-progressive SCI (no negative change in the neurological level and motor-completeness assessed during screening when compared to the neurological status assessed at 6-mo period after injury or at least 6 months prior to the screening), non-ventilator dependence, motor-complete SCI according to the American Spinal Injury Association Impairment Scale (AIS) grade "A" or "B" above T5 spinal level; * sustained SCI at least 12 months prior to entering the study; * compared to the normative values for healthy population, at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) as detected by screening spirometry. Exclusion Criteria: Participants will be excluded from the study if there is a presence of * major pulmonary or cardiovascular disease, * ventilator dependence, * endocrine disorders, * malignancy, * marked obesity, * deep vein thrombosis, * HIV/AIDS-related illness, * secondary hypotension (anemia, hypervolemia, endocrine and neurological diseases), * major esophageal/gastrointestinal problem or other major medical illness contraindicated for respiratory training or testing. During screening, the potential participant will be asked whether she is pregnant or planning to become pregnant during the study period. Pregnant women are excluded from this study, as the risk to the fetus is unknown. No pregnancy test or birth control regimen will be required.

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Conditions

The condition(s) this trial relates to.

Respiration Disorders Respiratory Aspiration respiratory system disorder spinal cord injury

As listed by the trial registrant

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

Respiration disorders Spinal cord injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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 and Neuroscience Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

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