Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-03 @ 8:48 AM
Study NCT ID:
NCT02832804
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2016-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep log and actiwatch', 'timeFrame': 'Change from baseline at 1 week', 'description': 'Changes of sleep quality'}], 'secondaryOutcomes': [{'measure': 'questionnaire', 'timeFrame': 'Change from baseline at 1 month'}, {'measure': 'EEG spectrum analysis', 'timeFrame': 'Change from baseline at 1 month'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Change from baseline at 1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Insomnia']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .', 'detailedDescription': '* visit 1\n\n * to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)\n * EEG\n* visit 2-6\n\n * tDCS stimulation (monday \\~ friday)\n * anodal / cathodal / sham\n * to fill in a questionnaire (CGI, LSEQ, SSS, HADS)\n * analysis the results of sleep log and actigraphy\n* visit 7 : 1 week after treatment\n\n * to fill in a questionnaire (CGI, LSEQ, SSS, HADS)\n * analysis the results of sleep log and actigraphy\n * EEG\n* visit 8 : 1 month after treatment\n\n * to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)\n * analysis the results of sleep log'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (older than 19 years)\n* primary insomnia\n* right handed\n* agree with participation of this study\n\nExclusion Criteria:\n\n* diagnosed with epilepsy or history of seizure\n* change of antipsychotic drug within 1 month\n* under suspicion of sleep apnea or periodic limb movement disorder\n* mental retardation (IQ \\< 70)\n* pregnant woman'}, 'identificationModule': {'nctId': 'NCT02832804', 'briefTitle': 'Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients', 'orgStudyIdInfo': {'id': '1509-061-703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anodal stimulation', 'description': '10 person The patients treated by anodal stimulation (2mA) for 20 minutes', 'interventionNames': ['Device: transcranial Direct Current Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cathodal stimulation', 'description': '10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes', 'interventionNames': ['Device: transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham stimulation', 'description': '10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds', 'interventionNames': ['Device: transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['HDCstim (direct current stimulator)'], 'description': 'Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds', 'armGroupLabels': ['anodal stimulation', 'cathodal stimulation', 'sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ki-Young Jung, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ki-Young Jung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}