Trancutaneous Abdominal Stimulation on Bowel Function.

NCT04627168 | Unknown FDA Device

• 1 other identifier: MM 100-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Constipation

Keywords

spinal cord injury; stimulation; constipation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Spinal cord injured persons

EXPERIMENTAL

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

Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer

Persons without neurogenic bowel dysfunction

EXPERIMENTAL

Abled-bodied persons with chronic constipation.

Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer

Interventions

Non-invasive, surface electrical stimulation device, DS5 Digitimer DEVICE

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

Persons without neurogenic bowel dysfunction; Spinal cord injured persons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Amol Soin, M.D., MBA: lead

Study Sites (1)

Ohio Pain Clinic

Dayton, Ohio, 45458, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Constipation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amol Soin, MD

  Ohio Pain Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Model Details: Subjects will be assigned to 1 of 2 groups. The first subject group will include spinal cord injured persons presenting with constipation, the second group - able-bodied persons with chronic constipation. In both groups, subjects will receive transcutaneous abdominal electrical stimulation that will be delivered through commercially available equipment.

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 13, 2020
• Study Start: October 7, 2020
• Primary Completion: December 30, 2022
• Study Completion: February 28, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)