Trancutaneous Abdominal Stimulation on Bowel Function.

Study Overview
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Brief Summary
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This is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. Electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit.

Detailed Description
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This is a prospective, single-center, treatment feasibility study to determine the efficacy of electrical stimulation for bowel functions. The study will determine sensations elicited by non-invasive, transcutaneous abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. The electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit. Visits are anticipated to be no more than 5 hours.

Official Title
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The Effects of Transcutaneous Abdominal Stimulation on Bowel Function in Persons With Spinal Cord Injury and in Able-bodied Persons With Chronic Constipation.

Conditions
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Spinal Cord Injuries, Constipation

Intervention / Treatment
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* Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For spinal cord injury subject group: Traumatic or non-traumatic spinal cord injury; Constipation; Motor-complete or motor-incomplete spinal cord injury; Quadriplegia or paraplegia; Post-injury time ≥ 1 year; Neurogenic Bowel Dysfunction Score ≥ 7. For able-bodied subject group: Diagnosis of intestinal constipation according to the Rome IV criteria; Chronic constipation as defined by < 3 bowel movements per week for > 3 months. For both subject groups: Can read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits. Exclusion Criteria: Presence of any organic cause for intestinal constipation; Have chronic fecal incontinence; Have skin infection/lesion in the area of electrode application or systemic skin disease; Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc); Have symptomatic cardiac disease; Have uncontrolled diabetes; Presence of abdominal hernia; Have a stoma, rectal tear, or untreated hemorrhoids; Have a significant psychiatric disorder; For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child; Be participating in another clinical study that would confound data analysis; Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be assigned to 1 of 2 groups. The first subject group will include spinal cord injured persons presenting with constipation, the second group - able-bodied persons with chronic constipation. In both groups, subjects will receive transcutaneous abdominal electrical stimulation that will be delivered through commercially available equipment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal cord injured persons<br>Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction. | Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer<br>* Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.<br>|
| Experimental: Persons without neurogenic bowel dysfunction<br>Abled-bodied persons with chronic constipation. | Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer<br>* Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the occurrence of first stool | The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured. | 7 days | 
| Total defecation time (duration) | The time (duration) to complete total defecation following the stimulation. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, stimulation, constipation