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

Not Applicable

Not yet recruiting

• Conditions: Neurogenic Bowel; Spinal Cord Injuries
• Interventions: Behavioral: Abdominal Functional Electrical Stimulation

• Registration Number: NCT06345781
• Lead Sponsor: Craig Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2025-03
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abdominal Functional Electrical Stimulation	Abdominal Functional Electrical Stimulation	All participants enrolled will receive the intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Craig Hospital; 🇺🇸 Englewood, Colorado, United States