Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 10:47 PM
Study NCT ID:
NCT06897332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Brain Cortical Activity in Real and Immersive Virtual Reality Manual Dexterity Tasks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain cortical activity', 'timeFrame': 'Baseline (at rest: before task performance) and Day 1 (during each of the three task performances within the single study session)', 'description': 'Measures of brain cortical activity using EEG/fNIRS'}], 'secondaryOutcomes': [{'measure': 'Average speed', 'timeFrame': 'Day 1 (during each of the three task performances within the single study session)', 'description': 'Mean instant velocity of the upper extremity during task performance'}, {'measure': 'Maximal movement speed', 'timeFrame': 'Day 1 (during each of the three task performances within the single study session)', 'description': 'Peak instant velocity of the upper extremity during task performance'}, {'measure': 'Movement smoothness', 'timeFrame': 'Day 1 (during each of the three task performances within the single study session)', 'description': 'Spectral arc length of the normalised instant velocity (SPARC) of the upper extremity during task performance'}, {'measure': 'Variation of velocity', 'timeFrame': 'Day 1 (during each of the three task performances within the single study session)', 'description': 'Coefficient of variation of the instant velocity of the upper extremity during task performance'}, {'measure': 'Average distance between thumb and other fingers', 'timeFrame': 'Day 1 (during each of the three task performances within the single study session)', 'description': 'Mean distance between thumb and other fingers during task performance'}, {'measure': 'Variation of distance between thumb and other fingers', 'timeFrame': 'Day 1 (during each of the three task performances within the single study session)', 'description': 'Coefficient of variation of the distance between thumb and other fingers during task performance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain', 'Virtual Reality', 'EEG', 'fNIRS', 'Manual Dexterity']}, 'descriptionModule': {'briefSummary': 'With advances in technology, virtual reality (VR) is increasingly used in various fields, including rehabilitation, motor learning, and neuroscience. Its ability to provide controlled, immersive, and interactive environments makes it a valuable tool for training and assessment. However, despite its growing adoption, limited evidence exists on how cortical activation in VR compares to real-world conditions. Moreover, brain cortical activity during motor tasks, such as manual dexterity tasks, remains underexplored.\n\nThis study aims to compare brain cortical activity in real and immersive virtual reality settings during a manual dexterity task. Secondary objectives include:\n\n* Examining the relationship between brain cortical activity and kinematics in both conditions.\n* Comparing brain cortical activity between hand-tracking and controller-based interactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited through word-of-mouth within the Belgian population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Normal-to-corrected vision\n* Ability to understand simple instructions\n\nExclusion Criteria:\n\n* History of seizure\n* Recent participation (within the last three months) in a study involving a manual dexterity task in immersive virtual reality\n* Neurologic or orthopaedic pathology potentially affecting upper extremity movement'}, 'identificationModule': {'nctId': 'NCT06897332', 'briefTitle': 'Comparing Brain Cortical Activity in Real and Immersive Virtual Reality Manual Dexterity Tasks', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Comparing Brain Cortical Activity in Real and Immersive Virtual Reality Manual Dexterity Tasks', 'orgStudyIdInfo': {'id': 'Real vs iVR Manual Dexterity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy individuals', 'interventionNames': ['Behavioral: Real-world manual dexterity task', 'Behavioral: Immersive virtual reality with controllers', 'Behavioral: Immersive virtual reality with hand-tracking']}], 'interventions': [{'name': 'Real-world manual dexterity task', 'type': 'BEHAVIORAL', 'description': 'Participants will perform a manual dexterity task involving the displacement of physical cubes', 'armGroupLabels': ['Healthy individuals']}, {'name': 'Immersive virtual reality with controllers', 'type': 'BEHAVIORAL', 'description': 'Participants will perform a manual dexterity task in an immersive virtual reality environment, requiring them to move virtual cubes using controllers', 'armGroupLabels': ['Healthy individuals']}, {'name': 'Immersive virtual reality with hand-tracking', 'type': 'BEHAVIORAL', 'description': 'Participants will perform a manual dexterity task in an immersive virtual reality environment, requiring them to move virtual cubes using the hand-tracking technology', 'armGroupLabels': ['Healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'contacts': [{'name': 'Gauthier Everard, PT, PhD', 'role': 'CONTACT', 'email': 'gauthier.everard@uclouvain.be', 'phone': '+32 472 500 158'}, {'name': 'Thierry Lejeune, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gauthier Everard, PT, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Neuro Musculo Skeletal Lab', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Gauthier Everard, PT, PhD', 'role': 'CONTACT', 'email': 'gauthier.everard@uclouvain.be', 'phone': '+32 472 500 158'}, {'name': 'Thérèse Ntabuhashe Bibentyo, Er, PhD student', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Thierry Lejeune, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc UCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Catholique de Louvain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}