Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-28 @ 12:43 AM
Study NCT ID:
NCT06999057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadriceps Motor Unit Adaptation to Simulated Knee Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Unit Recruitment (amplitude relative to recruitment threshold)', 'timeFrame': 'Baseline, 0, 30, and 60 minutes post-intervention', 'description': 'Measured via surface EMG decomposition'}, {'measure': 'Motor Unit Recruitment (firing rate relative to recruitment threshold)', 'timeFrame': 'Baseline, 0, 30, and 60 minutes post-intervention', 'description': 'Measured via surface EMG decomposition'}], 'secondaryOutcomes': [{'measure': 'Quadriceps Inhibition (Hoffmann Reflex)', 'timeFrame': 'Baseline, 0 and 60 minutes post-intervention', 'description': 'Measured with femoral nerve stimulation'}, {'measure': 'Isometric Peak Torque (Quadriceps Strength)', 'timeFrame': 'Baseline and 60 minutes post-intervention', 'description': 'Measured with isokinetic dynamometer (Biodex)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quadriceps', 'Electromyography', 'Motor Unit', 'Knee Effusion', 'Lidocaine', 'Deafferentation', 'Neuromuscular Adaptation', 'Muscle Strength'], 'conditions': ['Muscle Inhibition', 'Knee Injury Simulation']}, 'descriptionModule': {'briefSummary': 'This study investigates how simulated knee injury-via artificial joint effusion or deafferentation-affects quadriceps motor unit behavior in healthy young adults. Participants will complete neuromuscular testing during a single 2-hour lab session. This research seeks to improve understanding of muscle inhibition and inform interventions after real-world knee trauma.', 'detailedDescription': 'Using a controlled laboratory model, the investigators will simulate knee injury through two methods: (1) intra-articular saline injection to induce effusion, and (2) intra-articular lidocaine injection to induce sensory deafferentation. Healthy participants aged 18-30 will undergo surface and decomposition EMG, isometric strength testing, and reflex measurements before and after the intervention. The primary outcome is motor unit recruitment characteristics, with secondary outcomes including quadriceps inhibition (Hoffmann reflex) and isometric peak torque. The findings will inform future neuromodulatory approaches in rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-30 years\n2. Physically active (Tegner ≥ 5)\n3. No prior lower-limb surgery or major injury\n\nExclusion Criteria:\n\n1. Lower limb surgery or significant injury in past 2 years\n2. Cardiopulmonary, neurological, or psychiatric disorders\n3. Needle/electrical stimulation anxiety\n4. Medications affecting neuromuscular or psychological function\n5. Pregnancy\n6. Allergic to lidocaine\n7. Inability to elicit Hoffmann reflex'}, 'identificationModule': {'nctId': 'NCT06999057', 'briefTitle': 'Quadriceps Motor Unit Adaptation to Simulated Knee Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Florida'}, 'officialTitle': 'Quadriceps Motor Unit Adaptation to Simulated Knee Injury', 'orgStudyIdInfo': {'id': 'Knee_Injection_Study:6295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effusion Group', 'description': '60 mL sterile saline injected into knee', 'interventionNames': ['Device: Joint Effusion via 60 mL Sterile Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deafferentation Group', 'description': 'Lidocaine (single intra-articular dose)', 'interventionNames': ['Drug: Intra-articular Lidocaine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Sham procedure with fake needle', 'interventionNames': ['Other: Sham injection']}], 'interventions': [{'name': 'Joint Effusion via 60 mL Sterile Saline', 'type': 'DEVICE', 'description': 'Injection of sterile saline into the knee joint to simulate joint swelling and induce quadriceps inhibition.', 'armGroupLabels': ['Effusion Group']}, {'name': 'Intra-articular Lidocaine', 'type': 'DRUG', 'description': 'Injection of 7 mL lidocaine into the knee joint to simulate deafferentation by temporarily blocking sensory input.', 'armGroupLabels': ['Deafferentation Group']}, {'name': 'Sham injection', 'type': 'OTHER', 'description': 'Simulated knee injection using a stage needle without skin penetration, used to blind participants and serve as control.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Grant Norte, Ph.D.', 'role': 'CONTACT', 'email': 'Grant.Norte@ucf.edu', 'phone': '407-823-3188'}, {'name': 'Meredith Chaput, Ph.D.', 'role': 'CONTACT', 'email': 'Meredith.Chaput@ucf.edu'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The IPD and supporting documentation will be available beginning 6 months after publication of the primary manuscript. Data will remain available for 5 years following that date.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) related to primary and secondary outcomes, including motor unit recruitment characteristics, quadriceps strength, and Hoffmann reflex measurements, will be shared with qualified researchers upon reasonable request.', 'accessCriteria': 'Qualified researchers with appropriate data use agreements in place may request access. Requests should be submitted to the Principal Investigator via email and will be reviewed by the study team. Data will be shared via secure file transfer protocols.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Grant Norte', 'investigatorAffiliation': 'University of Central Florida'}}}}