Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT02212704
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2014-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verticality Perception - Multisensory Contribution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072458', 'term': 'Orientation, Spatial'}], 'ancestors': [{'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058585', 'term': 'Vestibular Evoked Myogenic Potentials'}], 'ancestors': [{'id': 'D019054', 'term': 'Evoked Potentials, Motor'}, {'id': 'D005071', 'term': 'Evoked Potentials'}, {'id': 'D000071080', 'term': 'Cortical Excitability'}, {'id': 'D055724', 'term': 'Electrophysiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2014-08-06', 'studyFirstSubmitQcDate': '2014-08-07', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions', 'timeFrame': 'During the turntable measurement (90 minutes)'}], 'secondaryOutcomes': [{'measure': 'relative contribution of head- and trunk-based sensory systems based on Bayesian modelling', 'timeFrame': 'while on the turntable (1.5 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vestibular', 'proprioception', 'spatial orientation', 'bayesian'], 'conditions': ['Verticality Perception in Healthy Human Subjects', 'Individual Contribution of Different Sensory Systems']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. To implement this assessment experimentally, the investigators will use a motor-driven 3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°) or aligned with the trunk. The investigators will then obtain measurements of the subjective visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The investigators hypothesize that different sensory input signals are combined in a statistically optimal fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 18-60 years\n* informed consent\n* absence of exclusion criteria\n\nExclusion Criteria:\n\n* peripheral-vestibular deficit\n* disturbed consciousness\n* history of sensory deficits\n* visual field deficits\n* other neurological or systemic disorder which can cause dementia or cognitive dysfunction\n* intake of antidepressants, sedatives, or neuroleptics\n* pregnancy, unless excluded by a negative pregnancy test\n* known neck pain or status post neck trauma'}, 'identificationModule': {'nctId': 'NCT02212704', 'briefTitle': 'Verticality Perception - Multisensory Contribution', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Verticality Perception - Dissociating Head and Trunk Contributors in Healthy Human Subjects', 'orgStudyIdInfo': {'id': 'perception_head_roll_zurich'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular stimulation', 'description': 'This is the experimental paradigm applied in all participants', 'interventionNames': ['Other: Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)', 'Other: 3D-video-head impulse testing', 'Other: Vestibular-evoked myogenic potentials (VEMPs)']}], 'interventions': [{'name': 'Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)', 'type': 'OTHER', 'armGroupLabels': ['Vestibular stimulation']}, {'name': '3D-video-head impulse testing', 'type': 'OTHER', 'description': 'Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study', 'armGroupLabels': ['Vestibular stimulation']}, {'name': 'Vestibular-evoked myogenic potentials (VEMPs)', 'type': 'OTHER', 'description': 'Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study', 'armGroupLabels': ['Vestibular stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Dept. of Neurology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Dominik Straumann, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Dept. of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}