Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 10:18 AM
Study NCT ID:
NCT01337908
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2011-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Mood and Stress After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples collected with Oragene kit.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'quality of life', 'disability'], 'conditions': ['Spinal Cord Injury', 'Depression']}, 'descriptionModule': {'briefSummary': 'This is a study of factors, such as pain, family support, psychological history and alcohol/substance use, that may influence whether a person experiences depression after their spinal cord injury.', 'detailedDescription': 'The objective of this study is to examine the degree to which vulnerability factors are mediated by stress to increase risk for depression after SCI in a sample of adults who sustained their injuries after the age of 18 years. Participants will complete a written survey (about pain, daily activities, social support and life experiences) and a telephone interview that will provide information about these factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women with a traumatic spinal cord injury who are 18 years of age and older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a spinal cord injury\n* Were age 16 years or older when injured\n* Sudden onset of symptoms\n\nExclusion Criteria:\n\n* Under 19 years old\n* Less than 1 year post-injury\n* had a non-traumatic injury'}, 'identificationModule': {'nctId': 'NCT01337908', 'briefTitle': 'A Study of Mood and Stress After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Survey of Vulnerability Factors, Current Stress and Depression Risk in Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'H133G070020'}}, 'contactsLocationsModule': {'locations': [{'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Rehabilitation Institute of Michigan', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wayne State University', 'class': 'OTHER'}, {'name': 'Santa Clara Valley Health & Hospital System', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Claire Z. Kalpakjian', 'investigatorAffiliation': 'University of Michigan'}}}}