Constipation, Spinal Cord Injuries
Conditions
Keywords
spinal cord injury, stimulation, constipation
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.
Interventions
DEVICENon-invasive, surface electrical stimulation device, DS5 Digitimer
Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.
Sponsors
Amol Soin, M.D., MBA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the occurrence of first stool | 7 days | The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured. |
| Total defecation time (duration) | 7 days | The time (duration) to complete total defecation following the stimulation. |
Countries
United States
Outcome results
None listed