NCT04627168

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Amol Soin, M.D., MBA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Non-invasive, surface electrical stimulation device, DS5 Digitimer	Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.

Timeline

• Start date: 2020-10-07
• Primary completion: 2022-12-30
• Completion: 2023-02-28
• First posted: 2020-11-13
• Last updated: 2022-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study