Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-29 @ 9:01 PM
Study NCT ID:
NCT04387357
Status:
UNKNOWN
Last Update Posted:
2020-05-13
First Post:
2020-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Imaging in the Study of Disorientation in the Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003221', 'term': 'Confusion'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-12', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatial disorientation', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Incidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Rate of change in heart rate will be measured using a wearable Photoplethysmography sensor'}, {'measure': 'Skin conductance', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor'}, {'measure': 'Accelerometry', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Incidences of change in movement behaviour and activity level will be measured using accelerometers'}, {'measure': 'Grey matter volume', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Rate of change in brain structural volume will be measured using a 3-Tesla scanner'}, {'measure': 'White matter integrity', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Rate of change in structural connectivity of brain white matter will be measured using a 3-Tesla scanner'}, {'measure': 'Resting-state functional connectivity', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Rate of change in functional connectivity of resting-state brain networks will be measured using a 3-Tesla scanner'}, {'measure': 'Interview responses', 'timeFrame': 'Up to 3 years from start of the study', 'description': 'Participants assessments of their sense of orientation are obtained using a structured interview.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Dementia', 'Disorientation', 'Older Adults', 'Magnetic Resonance Imaging']}, 'referencesModule': {'references': [{'pmid': '31362286', 'type': 'BACKGROUND', 'citation': 'Schaat S, Koldrack P, Yordanova K, Kirste T, Teipel S. Real-Time Detection of Spatial Disorientation in Persons with Mild Cognitive Impairment and Dementia. Gerontology. 2020;66(1):85-94. doi: 10.1159/000500971. Epub 2019 Jul 30.'}, {'pmid': '25180158', 'type': 'BACKGROUND', 'citation': "Ranasinghe KG, Hinkley LB, Beagle AJ, Mizuiri D, Dowling AF, Honma SM, Finucane MM, Scherling C, Miller BL, Nagarajan SS, Vossel KA. Regional functional connectivity predicts distinct cognitive impairments in Alzheimer's disease spectrum. Neuroimage Clin. 2014 Jul 23;5:385-95. doi: 10.1016/j.nicl.2014.07.006. eCollection 2014."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate whether markers of brain structure and function from MRI are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to Alzheimer's disease when walking through a real world environment.", 'detailedDescription': 'This is an experimental cross-sectional study which primarily aims at identifying characteristic features of spatial disorientation among people with mild cognitive impairment and dementia. The features of interest are motion and physiological related changes that occur during instances of spatial disorientation, which will be derived from wearable sensors.\n\nAdditionally, brain structure and functional connectivity changes associated with different levels of spatial orientation and gait parameters will also be investigated through resting-state functional imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy older adults and older adults with mild cognitive impairment or dementia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 years and above\n* Mini mental state examination (MMSE) ≥ 12 \\< 28 points for experimental group\n* Mini mental state examination (MMSE) ≥ 28 points for control group\n* Sufficient knowledge of German to understand participant information, declaration of consent and questionnaires\n* Dated and signed declaration of consent\n* Sufficient mobility and motivation to participate in the study\n\nExclusion Criteria:\n\n* Less than 50 years\n* Significantly impaired vision or hearing\n* Severely reduced mobility: cannot move around independently (even with aids)'}, 'identificationModule': {'nctId': 'NCT04387357', 'briefTitle': 'Multimodal Imaging in the Study of Disorientation in the Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University of Rostock'}, 'officialTitle': "Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases", 'orgStudyIdInfo': {'id': 'A-2012-0083'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Neurologically healthy older adults above the age of 50'}, {'label': 'Experimental', 'description': 'Older adults above the age of 50 with Mild Cognitive Impairment or Dementia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18147', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan J. Teipel, Prof. Dr.', 'role': 'CONTACT', 'email': 'stefan.teipel@med.uni-rostock.de', 'phone': '0049-381-494-9471'}, {'name': 'Stefan J. Teipel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'centralContacts': [{'name': 'Chimezie O Amaefule, M.Sc', 'role': 'CONTACT', 'email': 'chimezie.amaefule@dzne.de', 'phone': '0049-381-494-9478'}], 'overallOfficials': [{'name': 'Stefan J. Teipel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Rostock'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Rostock', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Center for Neurodegenerative Diseases (DZNE)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med', 'investigatorFullName': 'Stefan Teipel', 'investigatorAffiliation': 'University Medical Center Rostock'}}}}