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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Neurogenic Bowel
• Intervention / Treatment: Behavioral: Abdominal Functional Electrical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candy Tefertiller; Phone Number: 303-789-8000; Email: ctefertiller@craighospital.org
• Study Contact Backup: Name: Bria Mellick; Phone Number: 303-789-8757; Email: bmellick@craighospital.org

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • Craig Hospital
      • Contact: Bria Mellick, MS; Phone Number: 303-789-8757; Email: bmellick@craighospital.org
      • Contact: Candy Tefertiller; Email: ctefertiller@craighospital.org
      • Principal Investigator: Candy Tefertiller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Chronic SCI (> 12 months since injury) above the level of T11
2. > 18 years of age

3. 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.
4. Portable smart device with video capabilities and internet access
5. Willingness to access and/or download Zoom (videoconferencing software)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal Functional Electrical Stimulation; All participants enrolled will receive the intervention.	Behavioral: Abdominal Functional Electrical Stimulation; Functional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel Management Time (BMT)	This is measured by recording start and end time of bowel management session in study diary.	Daily (Weeks 1-10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel Management Strategy	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.	Daily (Weeks 1-10)
Stimulation Dose	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.	During active stimulation period (Weeks 3-7)
EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire	Quality of Life measure	Week 1, Week 3, Week 7, Week 10
International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire	This instrument measures participant-reported bowel function bowel function.	Week 1, Week 3, Week 7, Week 10
Visual Analog Scale (VAS)	This instrument measures participant perceptions of bowel function satisfaction on a rating scale from 0-100.	Week 1, Week 3, Week 7, Week 10
Neurogenic Bladder Symptom Score (NBSS)	This instrument measures neurogenic bladder symptoms	Week 1, Week 3, Week 7, Week 10
Intervention Acceptability	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	Week 7
Intervention Safety	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.	Daily (Weeks 0-10)

Collaborators and Investigators

• Sponsor: Craig Hospital
• Collaborators: Neuroscience Research Australia

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Neurogenic Bowel; Functional Electrical Stimulation (FES)
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Neurogenic Bowel
• Other Study ID Numbers: 2174433-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No