Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT02573402
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Argyrios.Stampas@uth.tmc.edu', 'phone': '(713) 797-5007', 'title': 'Argyrios Stampas, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'About 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Deep Vein Thrombosis/Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'about 4 weeks', 'description': 'All infections were urinary tract infections (UTIs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'about 4 weeks', 'description': 'Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'about 4 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, about 30 minutes', 'description': 'Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject\'s "mean change in pain score": \\[Average of the post-stimulation measurements for all 10 time points\\] minus \\[Average of baseline measurements for all 10 time points time point\\] = \\[mean change in pain score\\]. The value reported is the mean of all participants\' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Detrusor Pressure as Evaluated by Urodynamic Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '21', 'groupId': 'OG000'}, {'value': '33', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Detrusor Pressure as Evaluated by Urodynamic Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.'}, {'type': 'SECONDARY', 'title': 'Maximum Bladder Capacity as Evaluated by Urodynamic Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '580', 'spread': '45.7', 'groupId': 'OG000'}, {'value': '571', 'spread': '81.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Bladder Capacity as Evaluated by Urodynamic Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'classes': [{'categories': [{'measurements': [{'value': '552.6', 'spread': '110', 'groupId': 'OG000'}, {'value': '459.6', 'spread': '156.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.\n\nTranscutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control (Sham stimulation).\n\nControl: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.3', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neurologic Level Number', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The neurologic level number indicates the degree of neurologic functioning, with higher numbers indicating a higher degree of neurologic functioning. This is a continuous scale with 30 levels beginning at C1 (closest to the head) and moving caudal along the body to S5--C1 corresponds to level 1 and S5 corresponds to level 30.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Days from Injury', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '20.5', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Admission Functional Independence Measure (FIM) motor subscale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '16.6', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The FIM motor subscale consists of 13 items: Eating, Grooming, Bathing, Dressing (upper body), Dressing (lower body), Toileting, Bladder management, Bowel management, Transfers (bed/chair/wheelchair), Transfers (toilet), Transfers (bath/shower), Walk/wheelchair, and Stairs. Each individual item is scored from 1 to 7. The range of total scores is 13 to 91, with a higher score indicating more independence in performing the task associated with each item.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Admission Functional Independence Measure (FIM) bladder item', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'BG000'}, {'value': '1', 'spread': '0', 'groupId': 'BG001'}, {'value': '1', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The FIM bladder item (which is part of the FIM motor subscale) is scored from 1 to 7, with a range of possible scores from 1 to 7. A higher score indicates more independence in bladder management.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Admission Functional Independence Measure (FIM) cognition subscale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '5', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The FIM cognitive subscale consists of 5 items: Comprehension, Expression, Social interaction, Problem solving, and Memory. Each individual item is scored from 1 to 7. The range of total scores is 5 to 35, with a higher score indicating more independence in performing the task associated with each item.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants with Tetraplegia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Injuries are classified in as being neurologically "complete" or "incomplete" based "Sacral Sparing," which refers to the presence of sensory or motor function in the most caudal sacral segments as determined by the examination (i.e. preservation of light touch or pin prick sensation at the S4-5 dermatome, DAP or voluntary anal sphincter contraction). A complete injury is defined as the absence of sacral sparing, whereas an incomplete injury is defined as the presence of sacral.\n\nGrade A = Complete. No sensory or motor function is preserved in the sacral segments S4-S5.', 'unitOfMeasure': 'Participants'}, {'title': 'American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade B', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'See ASIA Grade A baseline measure description for further description of ASIA grading.\n\nGrade B = Sensory incomplete. Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body.', 'unitOfMeasure': 'Participants'}, {'title': 'American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'See ASIA Grade A baseline measure description for further description of ASIA grading.\n\nGrade C = Motor incomplete. Motor function is preserved below the neurological level of injury, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2).', 'unitOfMeasure': 'Participants'}, {'title': 'American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade D', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'See ASIA Grade A baseline measure description for further description of ASIA grading.\n\nD = Motor incomplete. Motor function is preserved below the neurological level of injury, and at least half (half or more) of key muscle functions below the neurological level of injury have a muscle grade \\>3.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-04', 'size': 1121649, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-07T16:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2015-10-05', 'resultsFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-09', 'studyFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Infection', 'timeFrame': 'about 4 weeks', 'description': 'All infections were urinary tract infections (UTIs).'}, {'measure': 'Number of Participants With Skin Irritation', 'timeFrame': 'about 4 weeks', 'description': 'Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.'}, {'measure': 'Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital', 'timeFrame': 'about 4 weeks'}, {'measure': 'Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)', 'timeFrame': 'baseline, about 30 minutes', 'description': 'Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject\'s "mean change in pain score": \\[Average of the post-stimulation measurements for all 10 time points\\] minus \\[Average of baseline measurements for all 10 time points time point\\] = \\[mean change in pain score\\]. The value reported is the mean of all participants\' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain.'}], 'secondaryOutcomes': [{'measure': 'Maximum Detrusor Pressure as Evaluated by Urodynamic Study', 'timeFrame': 'baseline'}, {'measure': 'Maximum Detrusor Pressure as Evaluated by Urodynamic Study', 'timeFrame': '2 weeks'}, {'measure': 'Maximum Bladder Capacity as Evaluated by Urodynamic Study', 'timeFrame': 'baseline'}, {'measure': 'Maximum Bladder Capacity as Evaluated by Urodynamic Study', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['electric stimulation', 'urodynamic study'], 'conditions': ['Spinal Cord Injury', 'Neurogenic Bladder']}, 'referencesModule': {'references': [{'pmid': '30837835', 'type': 'DERIVED', 'citation': 'Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).", 'detailedDescription': 'In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Enrollment within 6 weeks of injury\n* Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord.\n* Location and transportation available for follow-up appointments\n\nExclusion Criteria:\n\n* History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy\n* Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.)\n* History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)\n* Pregnancy\n* History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)\n* Morbid obesity\n* Ventilator dependent respiration\n* Significant autonomic dysreflexia during baseline urodynamic study."}, 'identificationModule': {'nctId': 'NCT02573402', 'briefTitle': 'The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'HSC-MS-15-0806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.', 'interventionNames': ['Device: Transcutaneous Tibial Nerve Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Sham stimulation.', 'interventionNames': ['Device: Control']}], 'interventions': [{'name': 'Transcutaneous Tibial Nerve Stimulation', 'type': 'DEVICE', 'description': '10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.', 'armGroupLabels': ['Transcutaneous Tibial Nerve Stimulation']}, {'name': 'Control', 'type': 'DEVICE', 'description': '10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Argyrios Stampas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Houston Health Science Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Institute for Rehabilitation and Research (TIRR)', 'class': 'UNKNOWN'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'University of Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Argyrios Stampas, MD', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}