Electrical Stimulation for Spinal Cord Injury

Overseen By Bria Mellick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Disqualifiers: Bowel conditions, Obesity, Gastrointestinal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with chronic spinal cord injury who experience neurogenic bowel dysfunction. It aims to help them manage their bowel function better and improve their quality of life related to bowel management.

Inclusion Criteria

Willingness to access and/or download Zoom (videoconferencing software)

I am older than 18 years.

My spinal cord injury is above T11 and happened over a year ago.

Exclusion Criteria

Self-reported bowel management time (BMT) of <30 minutes

Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)

Primary language other than English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abdominal functional electrical stimulation to improve bowel management time

10 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abdominal Functional Electrical Stimulation

Trial Overview The study tests the effectiveness of Abdominal Functional Electrical Stimulation (FES) in reducing the time needed for bowel management, enhancing quality of life, improving bladder symptoms, and potentially decreasing unplanned hospital visits.

Participant Groups

Group I: Abdominal Functional Electrical Stimulation Experimental Treatment 1 Intervention

All participants enrolled will receive the intervention.

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

Neuroscience Research Australia

Collaborator

Trials

14

Recruited

1,800+