Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-15 @ 11:58 PM
Study NCT ID:
NCT02732561
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2016-03-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jkimball@wakehealth.edu', 'phone': '1 (336) 716-9702', 'title': 'James Kimball, MD', 'organization': 'Wake Forest Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Data analyses done usually only matched pairs.'}}, 'adverseEventsModule': {'timeFrame': 'from first patient, first visit to last patient, last visit. Approximately 2 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Device', 'description': 'Sham device\n\nSham device: Sham device', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'CES device. cranial electrotherapy stimulation device. Alpha Stim device\n\nAlpha Stim device: cranial electrotherapy stimulation device', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Device', 'description': 'Sham device\n\nSham device: Sham device'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'CES device. cranial electrotherapy stimulation device. Alpha Stim device\n\nAlpha Stim device: cranial electrotherapy stimulation device'}], 'classes': [{'categories': [{'measurements': [{'value': '13.00', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '18'}, {'value': '6.50', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0-50.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes matched pairs'}, {'type': 'PRIMARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Device', 'description': 'Sham device\n\nSham device: Sham device'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'CES device. cranial electrotherapy stimulation device. Alpha Stim device\n\nAlpha Stim device: cranial electrotherapy stimulation device'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '15'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': "Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell \\& \\& McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0-56). All of these scores are used to compute an overarching score that indicates a person's anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'includes only matched pairs'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Device', 'description': 'Sham device\n\nSham device: Sham device'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'CES device. cranial electrotherapy stimulation device. Alpha Stim device\n\nAlpha Stim device: cranial electrotherapy stimulation device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Device', 'description': 'Sham device\n\nSham device: Sham device'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'CES device. cranial electrotherapy stimulation device. Alpha Stim device\n\nAlpha Stim device: cranial electrotherapy stimulation device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2016-03-23', 'resultsFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-27', 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': '4 weeks', 'description': 'Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0-50.'}, {'measure': 'Anxiety', 'timeFrame': '4 weeks', 'description': "Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell \\& \\& McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0-56). All of these scores are used to compute an overarching score that indicates a person's anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This is a trial of the use of cranial electrostimulating therapy for depression and anxiety among homeless adults.', 'detailedDescription': 'Cranial Electrostimulating (CES) Therapy is a Food and Drug Administration (FDA) approved treatment for depression and anxiety. However, there are no known studies on the use of this device with homeless adults. The objectives of this study are as follows: 1) to evaluate the acceptability and feasibility of CES as a treatment for homeless adults; and 2) to evaluate the efficacy of CES for the treatment of anxiety and depressive symptoms among homeless adults. Participants will be randomly assigned to one of two treatments: sham (n=10) or CES (n=10). Changes in anxiety and depressive symptoms will be evaluated over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Competent (no legal guardian) males and females between the ages of 18 to 64\n* Currently homeless or recent experience of homelessness, and symptoms of anxiety or depression\n\nExclusion Criteria:\n\n* Younger than 18 and older than 65\n* Patients who have attempted suicide with within the past twelve months or have active suicidal ideation will be excluded for possible safety concerns\n* Self-reported illegal substance use in the past 30 days. Recent use of nicotine and alcohol will be allowed. However, those with current intoxication will be excluded\n* History of a seizure disorder.\n* Current history of autoimmune or endocrine disorder affecting the brain, unstable cardiac disease, history of skull fracture, or craniotomy\n* Patients with pacemakers or internal electronic devices like deep brain stimulation and cochlear implants\n* Women who are pregnant, nursing or planning to become pregnant\n* Diagnosis of Schizophrenia or Schizoaffective disorder'}, 'identificationModule': {'nctId': 'NCT02732561', 'briefTitle': 'The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety', 'orgStudyIdInfo': {'id': 'IRB00036461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Device', 'description': 'Sham device', 'interventionNames': ['Device: Sham device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'CES device. cranial electrotherapy stimulation device. Alpha Stim device', 'interventionNames': ['Device: Alpha Stim device']}], 'interventions': [{'name': 'Alpha Stim device', 'type': 'DEVICE', 'description': 'cranial electrotherapy stimulation device', 'armGroupLabels': ['Intervention']}, {'name': 'Sham device', 'type': 'DEVICE', 'description': 'Sham device', 'armGroupLabels': ['Sham Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27117', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'James Kimball, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}