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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345781
• Other study ID #: 2174433-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Craig Hospital
• Contact: Candy Tefertiller
• Phone: 303-789-8000
• Email: ctefertiller[@]craighospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bowel
• Spinal Cord Injuries
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Craig Hospital	Neuroscience Research Australia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire	Quality of Life measure	Week 1, Week 3, Week 7, Week 10
Secondary	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
Secondary	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
Secondary	Neurogenic Bladder Symptom Score (NBSS)	This instrument measures neurogenic bladder symptoms	Week 1, Week 3, Week 7, Week 10
Secondary	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
Secondary	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)