Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 8:00 PM
Study NCT ID:
NCT06991933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction and Educational Impact of Plastination Models of the Limbic System, Basal Nuclei, Cerebellum, and Human Spinal Cord
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-10', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neuroanatomy knowledge scores assessed by the "Neuroanatomy Knowledge Assessment Test', 'timeFrame': 'Baseline, Week 4 post-intervention', 'description': 'Scale Title: Neuroanatomy Knowledge Assessment Test (NKAT). Score Range: 0 (no correct answers) to 15 (all answers correct). Interpretation: Higher scores indicate better neuroanatomy knowledge (better outcome).'}], 'secondaryOutcomes': [{'measure': 'Spatial understanding assessment', 'timeFrame': 'Post-intervention only', 'description': 'Method: 3D spatial reasoning test (modified Vandenberg scale)\n\nScoring: 1-5 Likert scale for structure identification accuracy'}, {'measure': 'Student satisfaction assessed by the 10-item Student Satisfaction Survey (SSS)', 'timeFrame': 'Immediately after the intervention (Day 1)', 'description': '* Score Range: 1 (strongly disagree) to 5 (strongly agree).\n* Interpretation: Higher scores indicate greater satisfaction (better outcome).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical education', 'Neuroanatomy', 'plastination model'], 'conditions': ['Education', 'Education, Medical', 'Education, Medical, Undergraduate']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nThis educational trial aims to assess whether plastination models for neuroanatomy training (limbic system, basal ganglia, cerebellum, spinal cord)" improve medical students\' understanding of central nervous system anatomy compared to traditional educational methods. It will also evaluate student satisfaction with this teaching tool.\n\nKey Questions:\n\n1. Do plastination models for neuroanatomy training (limbic system, basal ganglia, cerebellum, spinal cord) enhance test scores in neuroanatomy examinations?\n2. How do students perceive the educational value of these models?\n\nStudy Design:\n\nResearchers will compare two teaching methods:\n\n* Intervention group: Learns using plastination models for neuroanatomy training (limbic system, basal ganglia, cerebellum, spinal cord)\n* Control group: Learns using standard 2D atlases, power point and plastic models\n\nParticipants will:\n\n1. Complete a pre-intervention anatomy knowledge test\n2. Attend 4 weekly neuroanatomy sessions using their assigned method\n3. Take a post-intervention exam and satisfaction survey\n4. Participate in focus groups about their learning experience'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical students in their third semester of training\n* Currently enrolled in neuroanatomy coursework at Isfahan University of Medical Sciences\n* No prior formal training with plastinated models\n* Willing to attend all study sessions for 7 weeks\n* Able to complete assessments in persian\n\nExclusion Criteria:\n\n* Prior experience with plastinated models\n* Currently taking neuroanatomy remediation courses\n* Planned absences during \\>20% of study sessions'}, 'identificationModule': {'nctId': 'NCT06991933', 'briefTitle': 'Construction and Educational Impact of Plastination Models of the Limbic System, Basal Nuclei, Cerebellum, and Human Spinal Cord', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Preparation and Construction of Volumetric Plastination Models of the Limbic System, Basal Nuclei, Cerebellum, and Human Spinal Cord and Evaluation of Their Educational Effects', 'orgStudyIdInfo': {'id': 'IR.ARI.MUI.REC.1404.007'}, 'secondaryIdInfos': [{'id': '1403315', 'type': 'OTHER_GRANT', 'domain': 'Isfahan university medical sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 : Plastination Model Group', 'description': 'Receives instruction using plastinated models of:\n\n* Brainstem\n* Limbic system\n* Basal ganglia\n* Cerebellum\n* Spinal cord\n\nDuration: 7 weeks of training (2 hours/week)\n\nTaught by professor who every year teaches neuroanatomy\n\nAssessment: Standardized anatomy exams + spatial reasoning tests', 'interventionNames': ['Behavioral: Plastination Model Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Methods Group', 'description': "Receives equivalent instruction using:\n\n* Standard textbook and 2D atlases (e.g., Netter's)\n* Lectures with 2D projections\n\nMatched in duration and instructor expertise\n\nSame assessment protocol as an experimental group", 'interventionNames': ['Behavioral: Traditional Methods Group']}], 'interventions': [{'name': 'Plastination Model Group', 'type': 'BEHAVIORAL', 'description': 'Model Specifications:\n\n"S10 silicone plastination models of brainstem structures (1:1 scale) with:\n\n• Sectioned at 2mm intervals to reveal internal architecture', 'armGroupLabels': ['Arm 1 : Plastination Model Group']}, {'name': 'Traditional Methods Group', 'type': 'BEHAVIORAL', 'description': "1. Netter's Atlas of Human Anatomy (9th ed.)\n2. Standardized PowerPoint lectures", 'armGroupLabels': ['Traditional Methods Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mehrnoush Malekzadeh, Ph.D', 'role': 'CONTACT', 'email': 'mehrnoush.malekzadeh@med.mui.ac.ir', 'phone': '09133097258'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'mehrnoush malekzadeh', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}