Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT03722095
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2018-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Effects of Combined Neurostimulation Protocols on Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in heart rate variability (HRV)', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Variability in time between two heartbeats'}], 'secondaryOutcomes': [{'measure': 'Changes in heart rate (HR)', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Beats per minute'}, {'measure': 'Changes in blood pressure (BP)', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Both systolic and diastolic blood pressure (SBP/DBP)'}, {'measure': 'Changes in electrodermal activity (EDA)', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Peak amplitudes of Skin Conductive Responses (SCRs)'}, {'measure': 'Changes in state-dependent mood', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Visual analogue scales (VAS): total scores will be reported (range 0 to 10) with higher scores indicating worse outcome'}, {'measure': 'Changes in state-dependent ruminative thinking', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Brief State Rumination Inventory (BSRI): total scores will be reported (range 0 to 80) with higher scores indicating worse outcome'}, {'measure': 'Changes in anxiety features - self-report', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'State/Trait Anxiety Inventory (STAI): total scores will be reported (range 0 to 160) with higher scores indicating worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-invasive Brain Stimulation', 'intermittent Theta Burst Stimulation (iTBS)', 'Transcranial Direct Current Stimulation (tDCS)', 'Dorsolateral Prefrontal Cortex', 'Stress reactivity', 'Stress-related Disorders', 'Major Depressive Disorder'], 'conditions': ['Stress Reaction', 'Stress Related Disorder', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The study examines the effects of the combined use of two different non-invasive brain stimulation (NIBS) techniques targeting the DLPFC on stress reactivity and recovery.', 'detailedDescription': 'Transcranial Direct Current Stimulation (tDCS) will be combined with intermittent Theta Burst Stimulation (iTBS) in order to maximize the effects coming from each of the techniques on their own. A group of 74 healthy participants wil be submitted to two different stimulation protocols (sham tDCS + active iTBS and active tDCS + active iTBS) with one-week in between and results on stress reactivity will be examined. In order to improve therapeutic protocols, this study with healthy participants is a crucial first step in order to further conduct clinical studies with psychiatric samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Aged between 18-45 years old\n\nExclusion Criteria:\n\n* The presence of psychiatric disorders\n* Usage of psychotropic medication\n* Any or cardiovascular neurological condition\n* Personal or family history of epilepsy or other neurological disorders\n* Unstable medical condition, as well as chronic pain conditions, (such as fibromyalgia) or increased blood pressure\n* Eye disease(s)\n* Current substance abuse\n* Inner ear prosthesis\n* Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)\n* Any implanted metal device in the head region\n* Metal objects or magnetic objects in the brain or around the head (only removable earrings \\& piercing are allowed)\n* Recent neurosurgical interventions\n* Pregnancy\n* Skin problems in the head region\n* Recent fractures or wounds on the hand'}, 'identificationModule': {'nctId': 'NCT03722095', 'briefTitle': 'Research on the Effects of Combined Neurostimulation Protocols on Stress', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'The Effects of Preconditioning Theta Burst Stimulation With Transcranial Direct Current Stimulation on Stress Regulation in Healthy Controls: a Double-blind Sham-controlled Study', 'orgStudyIdInfo': {'id': 'EC/2018/0866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active tDCS + active iTBS', 'description': 'Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.', 'interventionNames': ['Device: active tDCS', 'Device: iTBS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tDCS + active iTBS', 'description': 'Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.', 'interventionNames': ['Device: sham tDCS', 'Device: iTBS']}], 'interventions': [{'name': 'active tDCS', 'type': 'DEVICE', 'otherNames': ['active/anodal transcranial direct current stimulation'], 'description': 'A current of 2 milliampère (mA) through electrodes of 5x5cm.', 'armGroupLabels': ['active tDCS + active iTBS']}, {'name': 'sham tDCS', 'type': 'DEVICE', 'otherNames': ['sham transcranial direct current stimulation'], 'description': 'Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.', 'armGroupLabels': ['sham tDCS + active iTBS']}, {'name': 'iTBS', 'type': 'DEVICE', 'otherNames': ['intermittent theta burst stimulation'], 'description': '54 cycles with 10 bursts of 3 pulses, train duration of 2 seconds and intertrain intervals of 6 seconds, results in 1620 pulses at 110% resting motor threshold.', 'armGroupLabels': ['active tDCS + active iTBS', 'sham tDCS + active iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Chris Baeken, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ghent University, University Hospital Ghent'}, {'name': 'Marie-Anne Vanderhasselt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ghent University, University Hospital Ghent'}, {'name': 'Stefaan Van Damme, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'After study completion.', 'ipdSharing': 'YES', 'description': 'Data will be made public on the open science framework website.', 'accessCriteria': 'Open acces'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}