Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT06689592
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Transcranial Magnetic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability for the patients', 'timeFrame': '1 week', 'description': 'Rating of the usability of the treatment with the user experience questionnaire \\[1-7, 26 items, the higher the better\\] and open feedback'}, {'measure': 'Usability for the handlers/clinicians', 'timeFrame': '1 week', 'description': 'Rating of the usability of the treatment (home treatment) with the user experience questionnaire \\[1-7, 26 items, the higher the better\\] and open feedback'}, {'measure': 'Efficiancy 1', 'timeFrame': '1 week', 'description': 'Number of responders according the the clinical global impression change score for patients in the per protocol analysis'}, {'measure': 'Efficiancy 2', 'timeFrame': '1 week', 'description': 'Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)'}, {'measure': 'Stability of effects 1', 'timeFrame': '5 weeks', 'description': 'Number of responders according the the clinical global impression change score'}, {'measure': 'Stability of effects 2', 'timeFrame': '5 weeks', 'description': 'Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)'}], 'secondaryOutcomes': [{'measure': 'Course of the scores of the Hamilton depression rating scale', 'timeFrame': '1 week', 'description': 'Depression rating scale (0-65, the lower the better)'}, {'measure': 'Course of the scores of the Major Depression Inventory', 'timeFrame': '1 week', 'description': 'Depression inventory (0-50, the lower the better)'}, {'measure': 'Course of the scores of the WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)', 'timeFrame': '1 week', 'description': 'Quality of life scale inventory (4-20, the higher the better)'}, {'measure': 'Course of the scores of the Clincial Global Impression change', 'timeFrame': '1 week', 'description': 'Clincial Global Impression (1-7, the lower the better)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'For this study 5 patients will be treated with transcranial magnetic stimulation in their residence (home, nursing home).', 'detailedDescription': "An investigation of the feasibility of rTMS treatments outside a clinical-medical context (e.g. in a residential facility and/or at the patient's home) is to be carried out (5 patients in total). Before the actual start of the study, the test subjects are informed in detail about the experimental setup and the methods used, as well as about contraindications and possible side effects. Following the information session, the test subjects sign a declaration of consent and complete questionnaires with relevant information (demographic data, health data to rule out serious illnesses and diagnostic questionnaires). On this day, a TMS test with a few test pulses is also planned in order to familiarize the test subjects with the TMS and to evaluate their tolerance. The stimulation intensity (so-called motor threshold) is also determined as part of this. In the following week, the TMS treatment is carried out on 5 consecutive days with a further visit. Following the preparations, a protocol modified from the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol is carried out. For this purpose, the test subjects are treated in 5 sessions per day on 5 consecutive days (25 stimulations in total). An iTBS protocol (3 bursts at 50 Hz in 2 seconds, 8 second pause) with 1800 pulses should be used every hour, which means that the duration of a stimulation is approximately 10 minutes and a total of 9,000 pulses could be applied per day.\n\nThe individual sessions are monitored by a Medbo Regensburg employee on site. There should be a break of 50 minutes between each hourly stimulation. After the treatment, a follow-up should take place after 4 weeks with questionnaires and a short verbal evaluation. Each subject can voluntarily terminate participation in the study at any time without giving reasons and without negative consequences (except for the lack of treatment). If the participant's compliance is severely impaired, the study may be terminated by the investigator."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* leading diagnosis of a depressive episode according to ICD-10 in the context of a uni- or bipolar disorder\n* moderate depression according to the Hamilton Depression Rating Scale\n* adult persons aged 18-80 of all genders\n* place of residence in Germany and understanding of the German language sufficient to understand the information\n* written declaration of consent\n\nExclusion Criteria:\n\n* Fulfillment of the contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps, skin diseases on the head)\n* The presence of a serious neurological disease (e.g. cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformation, severe head injuries in the medical history)\n* Participation in another study during the treatment\n* Pregnancy and breastfeeding period'}, 'identificationModule': {'nctId': 'NCT06689592', 'acronym': 'MTMS', 'briefTitle': 'Mobile Transcranial Magnetic Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Untersuchung Der Durchführbarkeit Von TMS-Behandlungen Zuhause - Mobile Transkranielle Magnetstimulation "MTMS"', 'orgStudyIdInfo': {'id': '24-3652-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile Transcranial Magnetic Stimulation', 'description': 'Transcranial Magnetic Stimulation at home. Half of the SAINT protocol (Cole et al., 2020, 2022) is to be carried out. For this purpose, all 5 test subjects are treated with 5 sessions per day on 5 consecutive days (25 stimulations in total). An iTBS protocol (3 pulses at 50 Hz in 2 seconds, 8 seconds pause) with 1800 pulses (total duration: 10 minutes) should be used every hour with a break of 50 minutes (total of 9,000 pulses can be applied per day).', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Intermittent theta burst stimulation', 'armGroupLabels': ['Mobile Transcranial Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Berthold Langguth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Regensburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, MD, Ph.D.', 'investigatorFullName': 'Berthold Langguth, MD, Ph.D.', 'investigatorAffiliation': 'University of Regensburg'}}}}