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NCT Number: NCT06345781

Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Nervous System Diseases Neurogenic Bowel Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Location status: Recruiting

Location contact

Bria Mellick, MS

CONTACT

[email protected]

303-789-8757

Candy Tefertiller

CONTACT

[email protected]

Candy Tefertiller

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic SCI (> 12 months since injury) above the level of T11
  • > 18 years of age
  • a measurable and consistent start and end event is determinable for the bowel routine
  • Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team.
  • Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.
  • Portable smart device with video capabilities and internet access
  • Willingness to access and/or download Zoom (videoconferencing software)

Exclusion criteria

  • American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
  • Self-reported bowel management time (BMT) of <30 minutes
  • Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
  • Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
  • Stoma or colostomy
  • No response to AFES (e.g., lower motor neuron impairment)
  • History of gastrointestinal surgery within the past 3 months
  • Severely obese participants (>40 BMI)
  • Primary language other than English
  • Previous history of uncontrolled, recurrent episodes of AD
  • Resting systolic blood pressure (BP) reported as >140 mmHg

Treatment and study plan

Abdominal Functional Electrical Stimulation

Behavioral

Functional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time.

Primary outcomes

  1. Bowel Management Time (BMT)

    Time frame: Daily (Weeks 1-10)

    This is measured by recording start and end time of bowel management session in study diary.

Secondary outcomes

  1. Bowel Management Strategy

    Time frame: Daily (Weeks 1-10)

    This will be measured via analysis of daily diary entries regarding bowel movements (time taken and frequency), dietary changes or inconsistencies, and use of laxatives and manual procedures. The bowel diary will be completed daily throughout the study by participants and/or their caregivers.

  2. Stimulation Dose

    Time frame: During active stimulation period (Weeks 3-7)

    This will be recorded by the participant. Participants will be asked to record the total time of active stimulation as displayed by the stimulation counter/timer and the intensity of the stimulation (milliamps) for each BM session in their bowel diary. The stimulation device will also record number of times the device button is depressed and duration in seconds, which can be downloaded at a later date by the research team providing further detail on stimulation dose.

  3. EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire

    Time frame: Week 1, Week 3, Week 7, Week 10

    Quality of Life measure

  4. International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire

    Time frame: Week 1, Week 3, Week 7, Week 10

    This instrument measures participant-reported bowel function bowel function.

  5. Visual Analog Scale (VAS)

    Time frame: Week 1, Week 3, Week 7, Week 10

    This instrument measures participant perceptions of bowel function satisfaction on a rating scale from 0-100.

  6. Neurogenic Bladder Symptom Score (NBSS)

    Time frame: Week 1, Week 3, Week 7, Week 10

    This instrument measures neurogenic bladder symptoms

  7. Intervention Acceptability

    Time frame: Week 7

    Qualitative and quantitative analysis of abdominal functional stimulation (AFES) use will be measured at the end of the active trial period, using both open-ended and 10-scored theoretical framework of acceptability questions to gain the perspective of people with lived experience of SCI on the use of AFES during a bowel routine

  8. Intervention Safety

    Time frame: Daily (Weeks 0-10)

    This will be determined by the reporting and summarization of any adverse events associated with the interventions. Participants will be instructed to record any adverse events in their bowel diaries and to call study staff immediately to review. Unplanned hospital visits will also be recorded in the study diary.

Study contacts

Contact information is provided by the study sponsor or research team.

Bria Mellick

CONTACT

[email protected]

303-789-8757

Candy Tefertiller

CONTACT

[email protected]

303-789-8000

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • Neuroscience Research Australia

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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