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New treatment option for Spinal Cord Injuries
Official title Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
ClinicalTrials.gov ID: NCT06345781
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.
You likely can't join 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)
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Englewood, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Englewood, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.