Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 2:00 PM
Study NCT ID:
NCT04627168
Status:
UNKNOWN
Last Update Posted:
2022-06-13
First Post:
2020-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trancutaneous Abdominal Stimulation on Bowel Function.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2020-11-01', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the occurrence of first stool', 'timeFrame': '7 days', 'description': 'The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.'}, {'measure': 'Total defecation time (duration)', 'timeFrame': '7 days', 'description': 'The time (duration) to complete total defecation following the stimulation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['spinal cord injury', 'stimulation', 'constipation'], 'conditions': ['Spinal Cord Injuries', 'Constipation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For spinal cord injury subject group:\n\n * Traumatic or non-traumatic spinal cord injury;\n * Constipation;\n * Motor-complete or motor-incomplete spinal cord injury;\n * Quadriplegia or paraplegia;\n * Post-injury time ≥ 1 year;\n * Neurogenic Bowel Dysfunction Score ≥ 7.\n* For able-bodied subject group:\n\n * Diagnosis of intestinal constipation according to the Rome IV criteria;\n * Chronic constipation as defined by \\< 3 bowel movements per week for \\> 3 months.\n* For both subject groups:\n\nCan read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits.\n\nExclusion Criteria:\n\n1. Presence of any organic cause for intestinal constipation;\n2. Have chronic fecal incontinence;\n3. Have skin infection/lesion in the area of electrode application or systemic skin disease;\n4. Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);\n5. Have symptomatic cardiac disease;\n6. Have uncontrolled diabetes;\n7. Presence of abdominal hernia;\n8. Have a stoma, rectal tear, or untreated hemorrhoids;\n9. Have a significant psychiatric disorder;\n10. For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child;\n11. Be participating in another clinical study that would confound data analysis;\n12. Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments."}, 'identificationModule': {'nctId': 'NCT04627168', 'briefTitle': 'Trancutaneous Abdominal Stimulation on Bowel Function.', 'organization': {'class': 'OTHER', 'fullName': 'Ohio Pain Clinic'}, 'officialTitle': 'The Effects of Transcutaneous Abdominal Stimulation on Bowel Function in Persons With Spinal Cord Injury and in Able-bodied Persons With Chronic Constipation.', 'orgStudyIdInfo': {'id': 'MM 100-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal cord injured persons', 'description': 'Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction.', 'interventionNames': ['Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer']}, {'type': 'EXPERIMENTAL', 'label': 'Persons without neurogenic bowel dysfunction', 'description': 'Abled-bodied persons with chronic constipation.', 'interventionNames': ['Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer']}], 'interventions': [{'name': 'Non-invasive, surface electrical stimulation device, DS5 Digitimer', 'type': 'DEVICE', 'description': 'Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.', 'armGroupLabels': ['Persons without neurogenic bowel dysfunction', 'Spinal cord injured persons']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45458', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pain Clinic', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}], 'overallOfficials': [{'name': 'Amol Soin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amol Soin, M.D., MBA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Amol Soin, M.D., MBA', 'investigatorAffiliation': 'Ohio Pain Clinic'}}}}