NCT06345781

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 28, 2024

Last Update Submit

March 26, 2026

Conditions

Spinal Cord InjuriesNeurogenic Bowel

Keywords

Spinal Cord InjuryFunctional Electrical Stimulation (FES)Neurogenic Bowel

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Bowel Management Strategy

    Daily (Weeks 1-10)

  • Stimulation Dose

    During active stimulation period (Weeks 3-7)

  • 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

  • Visual Analog Scale (VAS)

    Week 1, Week 3, Week 7, Week 10

  • +3 more secondary outcomes

Study Arms (1)

Abdominal Functional Electrical Stimulation

EXPERIMENTAL

All participants enrolled will receive the intervention.

Behavioral: Abdominal Functional Electrical Stimulation

Interventions

Abdominal Functional Electrical StimulationBEHAVIORAL

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

Abdominal Functional Electrical Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesNeurogenic Bowel

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Candy Tefertiller

CONTACT

303-789-8000ctefertiller@craighospital.org

Bria Mellick

CONTACT

303-789-8757bmellick@craighospital.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director of Research and Evaluation

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

April 30, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

US(1)