Trancutaneous Abdominal Stimulation on Bowel Function.

Amol Soin, M.D., MBA

Status: Active, not recruiting

Conditions: Spinal Cord Injuries; Constipation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04627168

MM 100-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Spinal cord injured persons

Experimental group

Description:

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

Treatment:

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

Persons without neurogenic bowel dysfunction

Experimental group

Description:

Abled-bodied persons with chronic constipation.

Treatment:

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