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Leg band could ease bowel troubles for spinal injury patients

NCT ID NCT07171489

Symptom relief Sponsor: University of Michigan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests a leg-worn device called AccelBand that uses mild electrical pulses to improve bowel function in people with spinal cord injury. One hundred participants will either receive active treatment or a sham (inactive) version for four weeks. Researchers will measure changes in bowel symptoms and colon transit time using X-rays.

What this could mean

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

Active substance
AccelBand (transcutaneous neuromodulation device)
What this could lead to
If it works, this could offer a non-drug, non-surgical way to manage bowel dysfunction after spinal cord injury.
What could go wrong
This is an early feasibility study with a small sample and sham control, so results may not confirm effectiveness. The device requires daily use and may not work for everyone.

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 100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 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: * Traumatic or non-traumatic spinal cord injury (SCI) * SCI level above the twelfth thoracic vertebra (T12) * SCI classified as Sensory Incomplete (AIS B), C, or D * Post-SCI time ≥ 6 months; * Neurogenic bowel dysfunction (NBD) as a result of SCI * Willing to sign the informed consent form Exclusion Criteria: * Significant cognitive impairment, impeding the ability to provide informed consent or complete the questionnaire * Prior gastrointestinal surgeries other than uncomplicated appendectomies, cholecystectomy or cesarean sections * Known diagnosis of diabetes mellitus * Known current or past severe significant psychiatric disorder * Known current substance abuse * Implanted medical devices for electrical stimulation (e.g. cardiac pacemaker) * Taking opioid medications on a regular daily basis * Currently pregnant or actively planning a pregnancy * Active inflammatory bowel disease * Ventilator dependency * Severe autonomic dysreflexia * No preservation of the sacral spinal reflexes: bulbocavernosus, patella, or Achilles * Complete absence of sensation in the leg (since it is needed for calibrating the TNM intensity)

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Conditions

The condition(s) this trial relates to.

neurogenic bowel spinal cord injury

As listed by the trial registrant

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

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

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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