Trancutaneous Abdominal Stimulation on Bowel Function.

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

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.

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.

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:

1. Presence of any organic cause for intestinal constipation;
2. Have chronic fecal incontinence;
3. Have skin infection/lesion in the area of electrode application or systemic skin disease;
4. Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);
5. Have symptomatic cardiac disease;
6. Have uncontrolled diabetes;
7. Presence of abdominal hernia;
8. Have a stoma, rectal tear, or untreated hemorrhoids;
9. Have a significant psychiatric disorder;
10. For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child;
11. Be participating in another clinical study that would confound data analysis;
12. Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.