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.

Study Overview

• Status: Active, not recruiting
• Conditions: Constipation; Spinal Cord Injuries
• Intervention / Treatment: Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45458
      • Ohio Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amol Soin, M.D., MBA
• Investigators: Principal Investigator: Amol Soin, MD, Ohio Pain Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: stimulation; spinal cord injury; constipation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Signs and Symptoms, Digestive; Trauma, Nervous System; Spinal Cord Diseases; Constipation; Spinal Cord Injuries
• Other Study ID Numbers: MM 100-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes