Trancutaneous Abdominal Stimulation on Bowel Function.

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04627168
• Other study ID #: MM 100-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: June 2022
• Source: Ohio Pain Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 28, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Spinal Cord Injuries

Intervention

Device:
• Non-invasive, surface electrical stimulation device, DS5 Digitimer
Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.

Locations

Country	Name	City	State
United States	Ohio Pain Clinic	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Amol Soin, M.D., MBA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total defecation time (duration)	The time (duration) to complete total defecation following the stimulation.	7 days