Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-08 @ 8:34 PM
Study NCT ID:
NCT02987933
Status:
UNKNOWN
Last Update Posted:
2016-12-09
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-08', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional brain connectivity', 'timeFrame': '6 months', 'description': 'Assessed by fMRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'fMRI', 'DTI'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '20506181', 'type': 'BACKGROUND', 'citation': 'Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.'}, {'pmid': '24623774', 'type': 'BACKGROUND', 'citation': 'Kucyi A, Moayedi M, Weissman-Fogel I, Goldberg MB, Freeman BV, Tenenbaum HC, Davis KD. Enhanced medial prefrontal-default mode network functional connectivity in chronic pain and its association with pain rumination. J Neurosci. 2014 Mar 12;34(11):3969-75. doi: 10.1523/JNEUROSCI.5055-13.2014.'}, {'pmid': '18256259', 'type': 'BACKGROUND', 'citation': 'Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.'}, {'pmid': '27182487', 'type': 'BACKGROUND', 'citation': 'Boeckle M, Schrimpf M, Liegl G, Pieh C. Neural correlates of somatoform disorders from a meta-analytic perspective on neuroimaging studies. Neuroimage Clin. 2016 Apr 10;11:606-613. doi: 10.1016/j.nicl.2016.04.001. eCollection 2016.'}, {'pmid': '20800649', 'type': 'BACKGROUND', 'citation': 'Tagliazucchi E, Balenzuela P, Fraiman D, Chialvo DR. Brain resting state is disrupted in chronic back pain patients. Neurosci Lett. 2010 Nov 12;485(1):26-31. doi: 10.1016/j.neulet.2010.08.053. Epub 2010 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals.', 'detailedDescription': 'Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans of normal subjects to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals. The analysis will use pattern recognition methods in a leave N out cross validation design. The success of the classifications will be the mean of all the validation runs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with daily chronic pain (\\> 6 months)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDaily Pain lasting for more than 6 months. Ages eligible for study are between 20 and 70 years.\n\nExclusion Criteria:\n\nAdults unable to consent Children, teenagers Pregnant women Prisoners Subjects who do not know English MRI exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02987933', 'briefTitle': 'The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brain Scan Inc.'}, 'officialTitle': 'The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions', 'orgStudyIdInfo': {'id': 'BSI001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Pain', 'description': 'Adults, \\> 6 months duration, daily pain'}, {'label': 'Healthy Normals', 'description': 'Age and gender matched controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David S Wack, Ph.D.', 'role': 'CONTACT', 'email': 'dswack@buffalo.edu', 'phone': '716-838-5889', 'phoneExt': '152'}], 'facility': 'WNY MRI', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'David S Wack, Ph.D.', 'role': 'CONTACT', 'email': 'dswack@buffalo.edu', 'phone': '716-838-5889', 'phoneExt': '152'}, {'name': 'David T Corey, Ph.D.', 'role': 'CONTACT', 'email': 'dcorey@brainscaninc.ca', 'phone': '855-822-7226'}], 'overallOfficials': [{'name': 'David S Wack, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo: SUNY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brain Scan Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'State University of New York at Buffalo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}