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Recruiting NCT06345781

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

No phase Interventional Spinal Cord Injuries Neurogenic Bowel

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abdominal Functional Electrical Stimulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Neurogenic Bowel. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Bowel Management Time (BMT) [Time frame: Daily (Weeks 1-10)]
Secondary outcome measures (8)
  • Bowel Management Strategy [Time frame: Daily (Weeks 1-10)]
  • Stimulation Dose [Time frame: During active stimulation period (Weeks 3-7)]
  • EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire [Time frame: Week 1, Week 3, Week 7, Week 10]
  • International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire [Time frame: Week 1, Week 3, Week 7, Week 10]
  • Visual Analog Scale (VAS) [Time frame: Week 1, Week 3, Week 7, Week 10]
  • Neurogenic Bladder Symptom Score (NBSS) [Time frame: Week 1, Week 3, Week 7, Week 10]
  • Intervention Acceptability [Time frame: Week 7]
  • Intervention Safety [Time frame: Daily (Weeks 0-10)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Craig Hospital — Englewood

Identifiers

NCT: NCT06345781 · 2174433-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗