Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-29 @ 7:09 AM
Study NCT ID:
NCT05188833
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2021-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG Results of Deep TMS in Patients With OCD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-26', 'studyFirstSubmitDate': '2021-12-26', 'studyFirstSubmitQcDate': '2021-12-26', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroencephalography', 'timeFrame': '6 weeks after baseline', 'description': 'It is an electrophysiological neuroimaging method frequently used in neuroscience and clinic, in which the activity between neural circuits can be measured and observed non-invasively in the form of electrical waves.'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Scale', 'timeFrame': '6 weeks after baseline', 'description': 'It is the scale used for evaluated the level of depression. Higher score means worse result.'}, {'measure': 'World Health Organization Quality of Life Scale Short Form', 'timeFrame': '6 weeks after baseline', 'description': 'It is the scale used for evaluated the level of quality of life. It contains a total of 26 questions. Higher score means better result.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obsessive compulsive disorder', 'Deep Transcranial Magnetic Stimulation', 'Mood', 'Quality of Life', 'EEG'], 'conditions': ['Obsessive-Compulsive Disorder', 'EEG With Periodic Abnormalities']}, 'descriptionModule': {'briefSummary': 'Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria\n\nExclusion Criteria:\n\n* Not volunteering to comply with the research program\n* Presence of a metal piece on the head\n* Having a pacemaker inserted\n* Having had a previous epileptic seizure'}, 'identificationModule': {'nctId': 'NCT05188833', 'briefTitle': 'EEG Results of Deep TMS in Patients With OCD', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients', 'orgStudyIdInfo': {'id': 'EEG.DeepTMS.OCD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Deep Transcranial Magnetic Stimulation', 'description': 'The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string.', 'interventionNames': ['Device: Deep Transcranial Magnetic Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Deep Transcranial Magnetic Stimulation and Paroxetine', 'description': 'The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied.', 'interventionNames': ['Device: Deep Transcranial Magnetic Stimulation', 'Drug: Paroxetine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paroxetine', 'description': "Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD.", 'interventionNames': ['Drug: Paroxetine']}], 'interventions': [{'name': 'Deep Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Deep TMS, unlike traditional TMS, is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, in addition to drug treatment and psychotherapy approaches, in addition to localized brain regions magnetic stimulation is a treatment method where disease symptoms are addressed.', 'armGroupLabels': ['Deep Transcranial Magnetic Stimulation', 'Deep Transcranial Magnetic Stimulation and Paroxetine']}, {'name': 'Paroxetine', 'type': 'DRUG', 'description': "Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression.", 'armGroupLabels': ['Deep Transcranial Magnetic Stimulation and Paroxetine', 'Paroxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34815', 'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Miray BUDAK, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}