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Electric jolts to abdominal muscles may restore cough power after spinal injury

NCT ID NCT05745298

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study investigates whether combining electrical stimulation of the abdominal and back muscles with specific breathing exercises can improve the strength of an unaided cough in people with acute spinal cord injury. Participants will use a device called the Xcite system to deliver electrical pulses to their muscles while performing respiratory training three days per week. The goal is to increase peak cough flow and other lung function measures, which could help clear mucus and reduce infection risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abdominal functional electrical stimulation (AFES) using the Xcite system plus respiratory muscle training exercises
What this could lead to
If successful, this approach could help people with spinal cord injury cough more effectively without assistance, reducing respiratory complications.
What could go wrong
This is an early-stage study with a small number of participants, so results may not apply to everyone. The intervention requires a positive response to electrical stimulation, which not all individuals may have.

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

Jul 2023

Expected to finish

Sep 2028

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: 1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date \< 12 months prior to enrollment 2. Positive response to electrical stimulation through a palpable contraction 3. Fluent in written and spoken English Exclusion Criteria: 1. Individuals who do not meet inclusion criteria 2. Prisoners 3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI 4. Individuals with open tracheostomy 5. Persons with pacemakers 6. Pregnant women 7. Persons with epilepsy 8. Open wounds or metal implants at site of electrode placement 9. Unresponsive to functional electrical stimulation 10. Current diagnosis or history of thoraco-abdomino-pelvic cancer

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

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

Acute spinal cord injury

How to take part

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  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

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Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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