Clinical trial NCT06345781: Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
Official title: Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neurogenic Bowel
Keywords: Spinal Cord Injury
Functional Electrical Stimulation (FES)
Neurogenic Bowel
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: Neuroscience Research Australia
First posted: 2024-04-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Bowel Management Time (BMT)
timeFrame: Daily (Weeks 1-10)
Secondary outcomes:
measure: Bowel Management Strategy
timeFrame: Daily (Weeks 1-10)
measure: Stimulation Dose
timeFrame: During active stimulation period (Weeks 3-7)
measure: EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
timeFrame: Week 1, Week 3, Week 7, Week 10
measure: International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire
timeFrame: Week 1, Week 3, Week 7, Week 10
measure: Visual Analog Scale (VAS)
timeFrame: Week 1, Week 3, Week 7, Week 10
measure: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: Week 1, Week 3, Week 7, Week 10
measure: Intervention Acceptability
timeFrame: Week 7
measure: Intervention Safety
timeFrame: Daily (Weeks 0-10)
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: