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

Craig Hospital

Status: Enrolling

Conditions: Neurogenic Bowel; Spinal Cord Injuries

Treatments: Behavioral: Abdominal Functional Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06345781

2174433-1

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Abdominal Functional Electrical Stimulation

Experimental group

Description:

All participants enrolled will receive the intervention.

Treatment:

Behavioral: Abdominal Functional Electrical Stimulation