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Clinical Trials/NCT06345781
NCT06345781RecruitingNot Applicable

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

Craig Hospital1 site in 1 country15 target enrollmentStarted: April 30, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
15
Locations
1
Primary Endpoint
Bowel Management Time (BMT)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Chronic SCI (> 12 months since injury) above the level of T11
  • •> 18 years of age
  • •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.
  • •Portable smart device with video capabilities and internet access
  • •Willingness to access and/or download Zoom (videoconferencing software)

Exclusion Criteria

  • •American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
  • •Self-reported bowel management time (BMT) of <30 minutes
  • •Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
  • •Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
  • •Stoma or colostomy
  • •No response to AFES (e.g., lower motor neuron impairment)
  • •History of gastrointestinal surgery within the past 3 months
  • •Severely obese participants (>40 BMI)
  • •Primary language other than English
  • •Previous history of uncontrolled, recurrent episodes of AD
  • •Resting systolic blood pressure (BP) reported as >140 mmHg

Arms & Interventions

Abdominal Functional Electrical Stimulation

Experimental

All participants enrolled will receive the intervention.

Intervention: Abdominal Functional Electrical Stimulation (Behavioral)

Outcomes

Primary Outcomes

Bowel Management Time (BMT)

Time Frame: Daily (Weeks 1-10)

This is measured by recording start and end time of bowel management session in study diary.

Secondary Outcomes

  • Bowel Management Strategy(Daily (Weeks 1-10))
  • Visual Analog Scale (VAS)(Week 1, Week 3, Week 7, Week 10)
  • Intervention Safety(Daily (Weeks 0-10))
  • EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire(Week 1, Week 3, Week 7, Week 10)
  • International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire(Week 1, Week 3, Week 7, Week 10)
  • Intervention Acceptability(Week 7)
  • Neurogenic Bladder Symptom Score (NBSS)(Week 1, Week 3, Week 7, Week 10)
  • Stimulation Dose(During active stimulation period (Weeks 3-7))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Candace Tefertiller

Executive Director of Research and Evaluation

Craig Hospital

Study Sites (1)

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