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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord injured persons | Experimental | Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction. |
|
| Persons without neurogenic bowel dysfunction | Experimental | Abled-bodied persons with chronic constipation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive, surface electrical stimulation device, DS5 Digitimer | Device | Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the occurrence of first stool | The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured. | 7 days |
| Total defecation time (duration) | The time (duration) to complete total defecation following the stimulation. | 7 days |
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Inclusion Criteria:
For spinal cord injury subject group:
For able-bodied subject group:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Amol Soin, MD | Ohio Pain Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio Pain Clinic | Dayton | Ohio | 45458 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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.
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| D014947 | Wounds and Injuries |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |