Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-03-02 @ 8:17 AM
Study NCT ID:
NCT01575106
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2012-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Neurobiology of Expectancy and Pain Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JKONG2@mgh.harvard.edu', 'phone': '617-726-7893', 'title': 'Jian Kong', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Heat Pain', 'description': 'All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.\n\nHeat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cream', 'description': 'All subjects were told they would receive lidocaine, capsaicin, and neutral cream on their forearm, but in reality they only received neutral cream (regular moisturizing lotion).', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin and tissue disorders', 'notes': 'itching, tenderness, and burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Response to Pain (0-20 Visual Analogue Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Heat Pain', 'description': 'There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.\n\nHeat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)'}], 'classes': [{'title': 'Pre-treatment placebo Lidocaine', 'categories': [{'measurements': [{'value': '10.7', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Pre-treatment placebo capsaicin', 'categories': [{'measurements': [{'value': '11', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Pre-treatment neutral', 'categories': [{'measurements': [{'value': '11.2', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment placebo lidocaine', 'categories': [{'measurements': [{'value': '8.1', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment placebo capsaicin', 'categories': [{'measurements': [{'value': '12.2', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment neutral', 'categories': [{'measurements': [{'value': '10.8', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1-3', 'description': 'Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Heat Pain', 'description': 'There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.\n\nHeat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)'}], 'classes': [{'title': 'Lidocaine', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Capsaicin', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).', 'unitOfMeasure': 'Post-Pre treatment peak beta', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The neutral cream is omitted from the data table below because we were only concerned about the direct comparison between positive expectancy ("Lidocaine") and negative expectancy ("Capsaicin") conditions. Data were only collected for the Lidocaine and Capsaicin creams.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Heat Pain', 'description': 'There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.\n\nHeat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Heat Pain', 'description': 'There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.\n\nHeat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2012-02-24', 'resultsFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2012-04-09', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-12', 'studyFirstPostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Response to Pain (0-20 Visual Analogue Scale)', 'timeFrame': 'Weeks 1-3', 'description': 'Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.'}, {'measure': 'fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex', 'timeFrame': 'Week 4', 'description': 'We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how contextual learning/expectation relieves or aggravates pain experience in the same cohort of subjects and the same study session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a) Healthy male and female adults aged 21-50\n* b) No contraindications to fMRI scanning\n* c) Right handed\n\nExclusion Criteria:\n\n* a) Current or past history of major medical, neurological, or psychiatric illness\n* b) Pregnancy or breast feeding, menopause, and irregular menstrual cycles (length of cycle must be within 26 to 32 days)\n* c) Claustrophobia\n* d) History of head trauma\n* e) History of impaired elimination\n* f) Instability of responses to experimental pain (see Study Procedures Section)\n* g) Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year\n* h) Non-fluent speaker of English'}, 'identificationModule': {'nctId': 'NCT01575106', 'briefTitle': 'The Neurobiology of Expectancy and Pain Perception', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin', 'orgStudyIdInfo': {'id': '2011P000663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.', 'interventionNames': ['Device: Heat pain applied using TSA or CHEPS']}], 'interventions': [{'name': 'Heat pain applied using TSA or CHEPS', 'type': 'DEVICE', 'description': 'TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'overallOfficials': [{'name': 'Jian Kong, MD,eq/MS/MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jian Kong', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}