Spinal Cord InjuriesNCT06345781
Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
A study testing Abdominal Functional Electrical Stimulation in people with Spinal Cord Injuries and Neurogenic Bowel, run by Craig Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bowel
- What is being tested?
- Abdominal Functional Electrical Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Craig Hospital
Englewood, Colorado, 80113
Candy Tefertiller, ctefertiller@craighospital.org
Bria Mellick, MS, 303-789-8757, bmellick@craighospital.org
About this study
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.
- Conditions
- Spinal Cord Injuries, Neurogenic Bowel
- Being tested
- Abdominal Functional Electrical Stimulation
- Keywords
- Spinal Cord Injury, Functional Electrical Stimulation (FES), Neurogenic Bowel
- Medical subject headings
- Spinal Cord Injuries, Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Functional Electrical StimulationBehavioural
Functional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Functional Electrical Stimulation | Experimental | All participants enrolled will receive the intervention. Receives: Behavioral: Abdominal Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Management Time (BMT)
This is measured by recording start and end time of bowel management session in study diary.
Measured: Daily (Weeks 1-10)
Secondary outcomes (8)
Bowel Management Strategy
This will be measured via analysis of daily diary entries regarding bowel movements (time taken and frequency), dietary changes or inconsistencies, and use of laxatives and manual procedures. The bowel diary will be completed daily throughout the study by participants and/or their caregivers.
Measured: Daily (Weeks 1-10)
Stimulation Dose
This will be recorded by the participant. Participants will be asked to record the total time of active stimulation as displayed by the stimulation counter/timer and the intensity of the stimulation (milliamps) for each BM session in their bowel diary. The stimulation device will also record number of times the device button is depressed and duration in seconds, which can be downloaded at a later date by the research team providing further detail on stimulation dose.
Measured: During active stimulation period (Weeks 3-7)
EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
Quality of Life measure
Measured: Week 1, Week 3, Week 7, Week 10
International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire
This instrument measures participant-reported bowel function bowel function.
Measured: Week 1, Week 3, Week 7, Week 10
Visual Analog Scale (VAS)
This instrument measures participant perceptions of bowel function satisfaction on a rating scale from 0-100.
Measured: Week 1, Week 3, Week 7, Week 10
Neurogenic Bladder Symptom Score (NBSS)
This instrument measures neurogenic bladder symptoms
Measured: Week 1, Week 3, Week 7, Week 10
Intervention Acceptability
Qualitative and quantitative analysis of abdominal functional stimulation (AFES) use will be measured at the end of the active trial period, using both open-ended and 10-scored theoretical framework of acceptability questions to gain the perspective of people with lived experience of SCI on the use of AFES during a bowel routine
Measured: Week 7
Intervention Safety
This will be determined by the reporting and summarization of any adverse events associated with the interventions. Participants will be instructed to record any adverse events in their bowel diaries and to call study staff immediately to review. Unplanned hospital visits will also be recorded in the study diary.
Measured: Daily (Weeks 0-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Apr 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroscience Research Australia
- Responsible party
- Principal investigator, Candace Tefertiller, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345781
- Sponsor's protocol ID
- 2174433-1
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06345781
- Acronym / sponsor ID
- 2174433-1
- Conditions
- Spinal Cord Injuries, Neurogenic Bowel
- Keywords
- Spinal Cord Injury, Functional Electrical Stimulation (FES), Neurogenic Bowel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- Neuroscience Research Australia
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Functional Electrical Stimulation | Experimental | Behavioral: Abdominal Functional Electrical StimulationAll participants enrolled will receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Portable smart device with video capabilities and internet access
- Willingness to access and/or download Zoom (videoconferencing software)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Functional Electrical StimulationFunctional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time. | Behavioural | Abdominal Functional Electrical Stimulation |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Functional Electrical Stimulation in people with Spinal Cord Injuries and Neurogenic Bowel, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candy Tefertiller (303-789-8000, ctefertiller@craighospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Management Time (BMT) (time frame: Daily (Weeks 1-10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.