Clinical trial NCT04627168: Trancutaneous Abdominal Stimulation on Bowel Function.
Official title: The Effects of Transcutaneous Abdominal Stimulation on Bowel Function in Persons With Spinal Cord Injury and in Able-bodied Persons With Chronic Constipation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Constipation
Keywords: spinal cord injury
stimulation
constipation
Lead sponsor: Ohio Pain Clinic
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Duration of the occurrence of first stool
timeFrame: 7 days
measure: Total defecation time (duration)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Ohio Pain Clinic
state: Ohio
Study officials:
affiliation: Ohio Pain Clinic
name: Amol Soin, MD
role: PRINCIPAL_INVESTIGATOR
References: