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

NCT ID: NCT06345781

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2025-12-31

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.

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abdominal Functional Electrical Stimulation

All participants enrolled will receive the intervention.

Group Type: EXPERIMENTAL

Abdominal Functional Electrical Stimulation

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuroscience Research Australia

OTHER

Sponsor Role: collaborator

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Candace Tefertiller

Executive Director of Research and Evaluation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Craig Hospital

Englewood, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Candy Tefertiller

Role: CONTACT

ctefertiller@craighospital.org

303-789-8000

Bria Mellick

Role: CONTACT

bmellick@craighospital.org

303-789-8757

Facility Contacts

Candy Tefertiller

Role: primary

ctefertiller@craighospital.org

Bria Mellick, MS

Role: backup

bmellick@craighospital.org

303-789-8757

Other Identifiers

2174433-1

Identifier Type: -

Identifier Source: org_study_id