Back to resultsTrancutaneous Abdominal Stimulation on Bowel Function.
Primary Purpose
Spinal Cord Injuries, Constipation
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive, surface electrical stimulation device, DS5 Digitimer
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, stimulation, constipation
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:
- 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.
Sites / Locations
- Ohio Pain Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Spinal cord injured persons
Persons without neurogenic bowel dysfunction
Arm Description
Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction.
Abled-bodied persons with chronic constipation.
Outcomes
Primary Outcome Measures
Duration of the occurrence of first stool
The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.
Total defecation time (duration)
The time (duration) to complete total defecation following the stimulation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04627168
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amol Soin, M.D., MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Constipation
Keywords
spinal cord injury, stimulation, constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord injured persons
Arm Type
Experimental
Arm Description
Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction.
Arm Title
Persons without neurogenic bowel dysfunction
Arm Type
Experimental
Arm Description
Abled-bodied persons with chronic constipation.
Intervention Type
Device
Intervention Name(s)
Non-invasive, surface electrical stimulation device, DS5 Digitimer
Intervention Description
Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.
Primary Outcome Measure Information:
Title
Duration of the occurrence of first stool
Description
The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.
Time Frame
7 days
Title
Total defecation time (duration)
Description
The time (duration) to complete total defecation following the stimulation.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol Soin, MD
Organizational Affiliation
Ohio Pain Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio Pain Clinic
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45458
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trancutaneous Abdominal Stimulation on Bowel Function.
We'll reach out to this number within 24 hrs