Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-07 @ 5:13 PM
Study NCT ID:
NCT02840760
Status:
UNKNOWN
Last Update Posted:
2018-02-26
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071057', 'term': 'Tardive Dyskinesia'}], 'ancestors': [{'id': 'D004409', 'term': 'Dyskinesia, Drug-Induced'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in motor evoked potential(MEP)', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in Abnormal Involuntary Movement Scale(AIMS）', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in cortical silent period', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in short interval intracortical inhibition(SICI）', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in intracortical facilitation(ICF）', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in Simpson-Angus Scale（SAS）', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in Barnes Akathisia Rating Scale（BARS）', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in Positive and Negative Syndrome Scale（PANSS）', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}, {'measure': 'Change from baseline in clinical global impression (CGI)', 'timeFrame': '2 times (Before treatment,immediately after treatment)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tardive dyskinesia.', 'rTMS'], 'conditions': ['Tardive Dyskinesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the therapeutic effect and mechanism of transcranial magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.', 'detailedDescription': 'The study was a parallel control design trial for 2 weeks. Patients with schizophrenia were treated with 10-Hz rTMS on left motor cortex (added to the ongoing treatment). Clinical symptoms and MEP were assessment before and after rTMS treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The diagnosis of schizophrenia according to DSM-IV；\n* At least two item of Abnormal Involuntary Movement Scale（AIMS） must be 2 points or higher\n* these symptoms are not from Parkinson，tourette's syndrome,huntington disease\n* Signed an informed consent\n\nExclusion Criteria:\n\n* rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure\n* patients to be diagnosed according to DSM-IV for substance abused, development delayed\n* current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines\n* Acute risk of suicide and impulse\n* history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG\n* pregnant and lactant women"}, 'identificationModule': {'nctId': 'NCT02840760', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.', 'orgStudyIdInfo': {'id': '15ZR1435600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tardive dyskinesia group', 'description': 'tardive dyskinesia group will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 30 stimuli each (i.e., 1800 stimuli) and an intertrain interval of 12 sec in primary motor cortex（M1）.', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control group'}], 'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Stimulate the primary motor cortex for 2 weeks.', 'armGroupLabels': ['tardive dyskinesia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dengtang Liu, MD', 'role': 'CONTACT', 'email': 'erliu110@126.com', 'phone': '+862164387250-73775'}], 'facility': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Dengtang Liu', 'role': 'CONTACT', 'email': 'erliu110@126.com', 'phone': '+86 21 64387250-73775'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}