Trancutaneous Abdominal Stimulation on Bowel Function.

Not Applicable

• Conditions: Spinal Cord Injuries; Constipation
• Interventions: Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer

• Registration Number: NCT04627168
• Lead Sponsor: Amol Soin, M.D., MBA

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-13
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal cord injured persons	Non-invasive, surface electrical stimulation device, DS5 Digitimer	Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction.
Persons without neurogenic bowel dysfunction	Non-invasive, surface electrical stimulation device, DS5 Digitimer	Abled-bodied persons with chronic constipation.

Primary Outcome Measures

Name	Time	Method
Total defecation time (duration)	7 days	The time (duration) to complete total defecation following the stimulation.
Duration of the occurrence of first stool	7 days	The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.

Trial Locations

Locations (1)

Ohio Pain Clinic; 🇺🇸 Dayton, Ohio, United States