Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-02-03 @ 2:17 PM
Study NCT ID:
NCT03275766
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2017-08-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sebastian.walther@upd.unibe.ch', 'phone': '+41 632 8979', 'title': 'Prof. Sebastian Walther', 'organization': 'University of Bern, University Hospital of Psychiatry, Bern'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial', 'description': 'inquiry with open questions', 'eventGroups': [{'id': 'EG000', 'title': 'DLPFC Facilitatory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC\n\nusually effective in depression treatment, probably no specific effect on psychomotor slowing\n\nDLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'preSMA/SMA Inhibitory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA\n\nshould inhibit overactive premotor cortices\n\nSMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'preSMA/SMA Facilitatory', 'description': 'intermittend theta burst stimulation (iTBS) over preSMA/SMA\n\nshould facilitate neural activity within premotor cortices\n\nSMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Sham TMS', 'description': 'sham rTMS with a placebo coil over occipital cortex\n\nshould have no effect at all (no transcranial magnetic stimulation, only sound)\n\nsham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'altered visual perception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Deterioration of psychiatric disorder', 'notes': 'one patient experienced a deterioration of the underlying psychiatric disorder (major depression), which required short term hospitalization. The intervention was stopped. The problem resolved and the patient was discharged from the hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Responders at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DLPFC Facilitatory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC\n\nusually effective in depression treatment, probably no specific effect on psychomotor slowing\n\nDLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli'}, {'id': 'OG001', 'title': 'preSMA/SMA Inhibitory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA\n\nshould inhibit overactive premotor cortices\n\nSMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli'}, {'id': 'OG002', 'title': 'preSMA/SMA Facilitatory', 'description': 'intermittend theta burst stimulation (iTBS) over preSMA/SMA\n\nshould facilitate neural activity within premotor cortices\n\nSMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli'}, {'id': 'OG003', 'title': 'Sham TMS', 'description': 'sham rTMS with a placebo coil over occipital cortex\n\nshould have no effect at all (no transcranial magnetic stimulation, only sound)\n\nsham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 3', 'description': 'Number of participants with \\>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied', 'unitOfMeasure': 'responders', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'observer based rating scale of the severity of psychomotor slowing, assessment blind to intervention Scores may range from 0 - 60, higher scores indicate worse outcome', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Activity Level From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Catatonia Severity From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Fingertapping Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Coin Rotation From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Hand Gesture Performance From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in SANS Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From HAMD Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in CAINS Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'the clinical assessment interview for negative symptoms, assessment blind to intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in PANSS Total and Subscores From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'the positive and negative syndrome scale, interview to assess severity of schizophrenia symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DLPFC Facilitatory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC\n\nusually effective in depression treatment, probably no specific effect on psychomotor slowing\n\nDLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli'}, {'id': 'FG001', 'title': 'preSMA/SMA Inhibitory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA\n\nshould inhibit overactive premotor cortices\n\nSMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli'}, {'id': 'FG002', 'title': 'preSMA/SMA Facilitatory', 'description': 'intermittend theta burst stimulation (iTBS) over preSMA/SMA\n\nshould facilitate neural activity within premotor cortices\n\nSMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli'}, {'id': 'FG003', 'title': 'Sham TMS', 'description': 'sham rTMS with a placebo coil over occipital cortex\n\nshould have no effect at all (no transcranial magnetic stimulation, only sound)\n\nsham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'DLPFC Facilitatory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC\n\nusually effective in depression treatment, probably no specific effect on psychomotor slowing\n\nDLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli'}, {'id': 'BG001', 'title': 'preSMA/SMA Inhibitory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA\n\nshould inhibit overactive premotor cortices\n\nSMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli'}, {'id': 'BG002', 'title': 'preSMA/SMA Facilitatory', 'description': 'intermittend theta burst stimulation (iTBS) over preSMA/SMA\n\nshould facilitate neural activity within premotor cortices\n\nSMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli'}, {'id': 'BG003', 'title': 'Sham TMS', 'description': 'sham rTMS with a placebo coil over occipital cortex\n\nshould have no effect at all (no transcranial magnetic stimulation, only sound)\n\nsham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '45.3', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '38.0', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '34.2', 'spread': '14.0', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '15.3', 'groupId': 'BG003'}, {'value': '39.5', 'spread': '15.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'major depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'schizophrenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'one subject randomized withdrew consent before the baseline assessments'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-20', 'size': 502953, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-26T06:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2017-08-22', 'resultsFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-11', 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responders at Week 3', 'timeFrame': 'week 3', 'description': 'Number of participants with \\>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied'}], 'secondaryOutcomes': [{'measure': 'Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'observer based rating scale of the severity of psychomotor slowing, assessment blind to intervention Scores may range from 0 - 60, higher scores indicate worse outcome'}, {'measure': 'Change in Activity Level From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h'}, {'measure': 'Change in Catatonia Severity From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention'}, {'measure': 'Change in Fingertapping Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment'}, {'measure': 'Change in Coin Rotation From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation'}, {'measure': 'Change in Hand Gesture Performance From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating'}, {'measure': 'Change in SANS Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention'}, {'measure': 'Change From HAMD Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention'}, {'measure': 'Change in CAINS Total Score From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'the clinical assessment interview for negative symptoms, assessment blind to intervention'}, {'measure': 'Change in PANSS Total and Subscores From Baseline to Week 3', 'timeFrame': 'week 3', 'description': 'the positive and negative syndrome scale, interview to assess severity of schizophrenia symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychomotor Retardation', 'Psychomotor Slowing', 'Schizophrenia and Related Disorders', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor slowing in schizophrenia or major depression.', 'detailedDescription': 'Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of rTMS in 3 weeks may ameliorate psychomotor slowing in schizophrenia or major depression.\n\nEligible participants will be randomized to one of four arms:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suffering from major depressive disorder or schizophrenia spectrum disorder according to DSM-5 criteria\n* right handedness\n* normal or corrected-to-normal vision and hearing\n\nExclusion Criteria:\n\n* epilepsy\n* history of severe head trauma\n* current abuse of drugs or alcohol; past addiction to drugs or alcohol\n* pregnancy\n* incompatibility to cerebral MRI'}, 'identificationModule': {'nctId': 'NCT03275766', 'briefTitle': 'Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders', 'orgStudyIdInfo': {'id': 'SNCTP610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DLPFC facilitatory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC\n\nusually effective in depression treatment, probably no specific effect on psychomotor slowing', 'interventionNames': ['Other: DLPFC facilitatory']}, {'type': 'EXPERIMENTAL', 'label': 'preSMA/SMA inhibitory', 'description': 'repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA\n\nshould inhibit overactive premotor cortices', 'interventionNames': ['Other: SMA inhibitory']}, {'type': 'EXPERIMENTAL', 'label': 'preSMA/SMA facilitatory', 'description': 'intermittend theta burst stimulation (iTBS) over preSMA/SMA\n\nshould facilitate neural activity within premotor cortices', 'interventionNames': ['Other: SMA facilitatory']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham TMS', 'description': 'sham rTMS with a placebo coil over occipital cortex\n\nshould have no effect at all (no transcranial magnetic stimulation, only sound)', 'interventionNames': ['Other: sham TMS']}], 'interventions': [{'name': 'DLPFC facilitatory', 'type': 'OTHER', 'otherNames': ['rTMS facilitatory DLPFC'], 'description': '15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli', 'armGroupLabels': ['DLPFC facilitatory']}, {'name': 'SMA inhibitory', 'type': 'OTHER', 'otherNames': ['rTMS inhibitory SMA'], 'description': '1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli', 'armGroupLabels': ['preSMA/SMA inhibitory']}, {'name': 'SMA facilitatory', 'type': 'OTHER', 'otherNames': ['iTBS facilitatory SMA'], 'description': 'Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli', 'armGroupLabels': ['preSMA/SMA facilitatory']}, {'name': 'sham TMS', 'type': 'OTHER', 'description': 'Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session', 'armGroupLabels': ['sham TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3008', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital of Psychiatry, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Sebastian Walther, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern, University Hospital of Psychiatry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr., Head of the outpatient clinic, University Hospital of Psychiatry', 'investigatorFullName': 'Sebastian Walther', 'investigatorAffiliation': 'University of Bern'}}}}