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Electric belly zaps may help spinal cord injury patients cough better

NCT ID NCT07626931

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device that electrically stimulates the abdominal muscles can improve cough strength in 150 adults with a recent spinal cord injury. Participants will use the device during breathing exercises for up to 6 weeks. The goal is to see if it helps clear mucus and reduces lung infections like pneumonia.

What this could mean

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

Active substance
Respiratory Muscle Stimulator (device)
What this could lead to
If it works, this could provide a non-drug way to strengthen cough and reduce pneumonia risk in people with spinal cord injury.
What could go wrong
This is an early-stage trial with 150 participants, so results may not apply to everyone. The device may not improve cough enough to prevent complications.

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 150 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 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. Adults (≥ 22 years of age) admitted to rehabilitation with a new SCI. 2. New non-progressive SCI occurring in the past 3 to 8 weeks. 3. Neurological level of injury of C1-T5. 4. American Spinal Injuries Association Impairment Scale A to C. 5. CPF of \<160 L/min (Note: A CPF of \<270 L/min has been shown to be associated with decreased secretion clearance and increased respiratory complications, while a CPF of \<160 L/min has been shown to lead to an ineffective cough). 6. Not dependent on mechanical ventilation (people dependent on mechanical ventilation are at greatly increased risk of respiratory complications and are excluded due to this heterogeneity). 7. Able to sit upright. 8. Expected to remain in rehabilitation for at least another 3 weeks. Exclusion Criteria: 1. Respiratory complications in previous 24 hours (screening out iatrogenic complications). 2. Chronic respiratory disease. 3. No contraction of the abdominal wall muscles in response to abdominal NMES. 4. Open abdominal surgery ≤ 4 weeks prior to enrollment. 5. Have yet to undergo spinal surgery to stabilize injury, where required. 6. Body mass index \>40 kg/m2. 7. Pacemaker (external or internal) or implanted electronic device (e.g., a defibrillator). 8. Known or expected to be pregnant. 9. Placed on a palliative/supportive care only pathway. 10. Receiving any of the following as standard of care: * Abdominal FES * Inspiratory or Expiratory muscle training * Transcutaneous or implanted thoracolumbar spinal stimulation 11. Participating in any of the following: * A study with the same or similar primary endpoint * A study investigating electrical stimulation or respiratory muscle therapy * Any study in which the investigator determines may interfere with the results of this study 12. Unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits including facial or dental trauma. 13. Any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results. 14. Unable to provide informed consent. 15. Unwilling to provide informed consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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