Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 6:09 PM
Study NCT ID:
NCT02616835
Status:
COMPLETED
Last Update Posted:
2015-11-30
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Physiology of Targeted Theta-burst Neuromodulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in functional connectivity following TMS administration using functional MRI', 'timeFrame': 'One hour', 'description': 'Changes in brain connectivity will be assessed by comparing functional MRI scans after theta-burst TMS and sham theta-burst TMS'}], 'secondaryOutcomes': [{'measure': 'Changes in brain metabolites following TMS administration using MR spectroscopy', 'timeFrame': 'One hour', 'description': 'Using MRI scans, changes in metabolites in the brain will be assessed following theta-burst TMS and sham TMS'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No personal history of neurological or psychiatric disorders\n\nExclusion Criteria:\n\n* Have had a brain injury or neurological disorder\n* Have ever suffered an epileptic fit\n* Have any non-removable metal implants\n* Drink more than 20 units of alcohol per week on a regular basis\n* Currently take any illicit drugs on regular basis\n* Likely to be pregnant\n* Ever suffered from a serious mental illness such as schizophrenia, severe depression or bipolar disorder\n* Currently take any psychotropic medication'}, 'identificationModule': {'nctId': 'NCT02616835', 'briefTitle': 'Investigating the Physiology of Targeted Theta-burst Neuromodulation', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mental Health Nottingham'}, 'officialTitle': 'Investigating the Physiology of Targeted Theta-burst Neuromodulation', 'orgStudyIdInfo': {'id': 'L14082014 SoM PAPsych'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'theta-burst TMS', 'description': 'Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)', 'interventionNames': ['Device: theta-burst TMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham theta-burst TMS', 'description': 'Sham protocol for theta-burst transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)', 'interventionNames': ['Device: sham theta-burst TMS']}], 'interventions': [{'name': 'theta-burst TMS', 'type': 'DEVICE', 'description': 'This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.', 'armGroupLabels': ['theta-burst TMS']}, {'name': 'sham theta-burst TMS', 'type': 'DEVICE', 'description': 'This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)', 'armGroupLabels': ['sham theta-burst TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2TU', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Sarina Iwabuchi', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Sarina Iwabuchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mental Health Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Sarina Iwabuchi', 'investigatorFullName': 'Sarina Iwabuchi', 'investigatorAffiliation': 'Institute of Mental Health Nottingham'}}}}