Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-13 @ 8:18 AM
Study NCT ID:
NCT03302793
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2017-10-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
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It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '30.4', 'spread': '25.53', 'groupId': 'OG000'}, {'value': '35.0', 'spread': '26.04', 'groupId': 'OG001'}]}]}, {'title': 'After tDCS', 'categories': [{'measurements': [{'value': '31.1', 'spread': '27.05', 'groupId': 'OG000'}, {'value': '33.9', 'spread': '26.37', 'groupId': 'OG001'}]}]}, {'title': 'After BreEstim', 'categories': [{'measurements': [{'value': '34.5', 'spread': '24.14', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '21.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 minutes after tDCS, 10 minutes after BreEstim', 'description': "Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. 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It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'After tDCS', 'categories': [{'measurements': [{'value': '7.4', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'After BreEstim', 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '2.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 minutes after tDCS, 10 minutes after BreEstim', 'description': "Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. 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It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.'}, {'id': 'FG001', 'title': 'M1 tDCS and Then BreEStim; Then Sham tDCS and Then BreEstim', 'description': 'This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "2 subjects only finished Combined active tDCS (M1) and BreEStim section, but didn't attend the Sham tDCS and BreEStim section."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-07', 'size': 546534, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-30T18:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-16', 'studyFirstSubmitDate': '2017-10-01', 'resultsFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2017-10-01', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-16', 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as Assessed by Visual Analogue Scale (VAS)', 'timeFrame': 'baseline, 10 minutes after tDCS, 10 minutes after BreEstim', 'description': "A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain."}], 'secondaryOutcomes': [{'measure': 'Electrical Pain Threshold', 'timeFrame': 'baseline, 10 minutes after tDCS, 10 minutes after BreEstim', 'description': "Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold."}, {'measure': 'Electrical Sensation Threshold', 'timeFrame': 'baseline, 10 minutes after tDCS, 10 minutes after BreEstim', 'description': "Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '30132010', 'type': 'RESULT', 'citation': 'Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.'}]}, 'descriptionModule': {'briefSummary': 'This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of spinal cord injury patients. Note that this study will also enroll healthy volunteers, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 75 years\n* male and female subjects\n* has neuropathic pain after traumatic spinal cord injury\n* has chronic pain, \\>3 months\n* is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)\n\nExclusion Criteria:\n\n* currently adjusting oral pain medications for their neuropathic pain\n* have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)\n* have a pacemaker, or other metal and/or implanted devices\n* have amputation in their arm(s)\n* have spinal cord injury (SCI) involving impairment of arms\n* have cognitive impairment from brain injury or are not able to follow commands, or to give consent\n* have asthma or other pulmonary disease\n* are not medically stable\n* have preexisting psychiatric disorders\n* alcohol or drug abuse\n* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.\n* Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.'}, 'identificationModule': {'nctId': 'NCT03302793', 'briefTitle': 'Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management', 'orgStudyIdInfo': {'id': 'HSC-MS-14-0564 SCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BreEStim and tDCS sham, then combined BreEStim and tDCS', 'description': 'BreEStim is voluntary breathing controlled electrical stimulation.', 'interventionNames': ['Device: BreEStim', 'Device: tDCS', 'Device: tDCS sham']}, {'type': 'EXPERIMENTAL', 'label': 'Combined BreEStim and tDCS, then BreEStim and tDCS sham', 'description': 'BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.', 'interventionNames': ['Device: BreEStim', 'Device: tDCS', 'Device: tDCS sham']}], 'interventions': [{'name': 'BreEStim', 'type': 'DEVICE', 'description': 'BreEStim will applied for 10 to 20 minutes.', 'armGroupLabels': ['BreEStim and tDCS sham, then combined BreEStim and tDCS', 'Combined BreEStim and tDCS, then BreEStim and tDCS sham']}, {'name': 'tDCS', 'type': 'DEVICE', 'description': 'tDCS will be applied for 20 minutes.', 'armGroupLabels': ['BreEStim and tDCS sham, then combined BreEStim and tDCS', 'Combined BreEStim and tDCS, then BreEStim and tDCS sham']}, {'name': 'tDCS sham', 'type': 'DEVICE', 'armGroupLabels': ['BreEStim and tDCS sham, then combined BreEStim and tDCS', 'Combined BreEStim and tDCS, then BreEStim and tDCS sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'TIRR', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sheng Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sheng Li', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}