Trancutaneous Abdominal Stimulation on Bowel Function.

NCT ID: NCT04627168

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2023-02-28

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.

Conditions

Spinal Cord Injuries; Constipation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal cord injured persons

Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction.

Group Type: EXPERIMENTAL

Non-invasive, surface electrical stimulation device, DS5 Digitimer

Intervention Type: DEVICE

Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.

Persons without neurogenic bowel dysfunction

Abled-bodied persons with chronic constipation.

Group Type: EXPERIMENTAL

Non-invasive, surface electrical stimulation device, DS5 Digitimer

Intervention Type: DEVICE

Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.

Interventions

Non-invasive, surface electrical stimulation device, DS5 Digitimer

Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amol Soin, M.D., MBA

OTHER

Sponsor Role: lead

Responsible Party

Amol Soin, M.D., MBA

Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amol Soin, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio Pain Clinic

Locations

Ohio Pain Clinic

Dayton, Ohio, United States

Countries

United States

Other Identifiers

MM 100-1

Identifier Type: -

Identifier Source: org_study_id