Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 9:10 PM
Study NCT ID:
NCT01317303
Status:
COMPLETED
Last Update Posted:
2013-11-04
First Post:
2011-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Measures of Plasticity
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2011-03-16', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amplitude of motor evoked potentials', 'timeFrame': '60 minutes post brain stimulation protocol intervention'}], 'secondaryOutcomes': [{'measure': "motor learning through performance on a 'rotor pursuit task'", 'timeFrame': 'time frame relates to 5 blocks of 5 trials for each participant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['paired associative stimulation', 'theta burst stimulation', 'transcranial magnetic stimulation', 'neuroplasticity', 'healthy controls'], 'conditions': ['Depression', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.blackdoginstitute.org.au', 'label': 'Black Dog Institute website'}]}, 'descriptionModule': {'briefSummary': "Neuroplasticity refers to the ability of the nerve cells to modify their structure or function in response to injury or insult, or other environmental stimuli, with these changes outlasting the period of exposure. Plasticity may be observed as short term or long term changes. In humans, neuroplasticity can be readily assessed in the motor cortex, as excitability changes are demonstrated in the degree to which peripheral muscles are activated, seen through changes in motor-evoked potentials (MEPs). In this study, a number of approaches to assessing neuroplasticity will be evaluated: Paired-associative stimulation (PAS), Theta Burst Stimulation (TBS), which is a form of transcranial magnetic stimulation (TMS) and protocols that combine these two. In addition, participants will complete a computerised 'rotor pursuit task' designed to provide a measure of motor learning.\n\nThe investigators aim to find the most efficacious (defined by greatest number of responders and effect size as seen in an increase in MEP amplitude) brain stimulation protocol. The investigators will expose the same participants to four excitatory conditioning stimulation paradigms, with each session separated by at least a week.\n\nOur hypotheses include:\n\nThe four conditioning stimulation protocols should increase motor cortical excitability, the investigators therefore expect there to be a significant increase in participant MEPs, with a positive correlation in the increase ofMEP amplitude of the protocols. The investigators do however expect that due to the principles of homeostatic metaplasticity, that the protocols preceded by cTBS will show greater MEP change, due to the lowering of the threshold for LTP plasticity induction. In addition, the investigators expect that an increase in the motor learning manifest by the rotor pursuit task and for there to be a correlation in participants between the increase in MEP amplitude and the improvement in time on target (TOT) shown in the motor learning task (MLT)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy controls\n* those suffering depression\n* aged\n\nExclusion Criteria:\n\n1. Significant Neurological illness, including epilepsy\n2. Alcohol use above NHRMC guidelines\n3. Illicit drug use\n4. Electronic implant; such as cochlear implant or pacemaker\n5. Musculoskeletal disorder'}, 'identificationModule': {'nctId': 'NCT01317303', 'briefTitle': 'Comparison of Measures of Plasticity', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'Comparison of Measures of Plasticity', 'orgStudyIdInfo': {'id': 'UNSW10106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAS25', 'description': "PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.", 'interventionNames': ['Procedure: PAS25']}, {'type': 'EXPERIMENTAL', 'label': 'cTBS-PAS', 'description': "40 seconds of continuous Theta-burst stimulation, followed by PAS25 which refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.", 'interventionNames': ['Procedure: cTBS-PAS25']}, {'type': 'EXPERIMENTAL', 'label': 'iTBS', 'description': '190 seconds of intermittent theta-burst stimulation', 'interventionNames': ['Procedure: iTBS']}, {'type': 'EXPERIMENTAL', 'label': 'cTBS-iTBS', 'description': '40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation', 'interventionNames': ['Procedure: cTBS-iTBS']}], 'interventions': [{'name': 'cTBS-PAS25', 'type': 'PROCEDURE', 'otherNames': ['Magstim,', 'Digitimer'], 'description': "40 seconds of continuous Theta-burst stimulation, followed by PAS25 which refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after", 'armGroupLabels': ['cTBS-PAS']}, {'name': 'cTBS-iTBS', 'type': 'PROCEDURE', 'description': '40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation', 'armGroupLabels': ['cTBS-iTBS']}, {'name': 'PAS25', 'type': 'PROCEDURE', 'otherNames': ['Magstim', 'Digitimer'], 'description': "PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.", 'armGroupLabels': ['PAS25']}, {'name': 'iTBS', 'type': 'PROCEDURE', 'otherNames': ['Magstim'], 'description': '190 seconds of intermittent theta-burst stimulation', 'armGroupLabels': ['iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Black Dog Institute, University of New South Wales', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Colleen Loo', 'investigatorAffiliation': 'The University of New South Wales'}}}}