Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-07 @ 9:05 PM
Study NCT ID:
NCT03380832
Status:
UNKNOWN
Last Update Posted:
2018-10-16
First Post:
2017-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motion Perception in Individuals With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2017-12-15', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vestibular threshold', 'timeFrame': '3 hours', 'description': 'Vestibular thresholds are measured while subjects sit in a chair that makes small motions in a variety of directions. After each motion, subjects press a button to report their perceived direction (e.g., did I rotate to the left or the right). The size of the motions is adjusted based on subject responses to find the level at which they get approximately 80% of responses correct.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Is the ability to perceive motion altered by diabetes? The investigators are measuring motion perception using a technique called vestibular thresholds. Subjects will undergo 3 hours of testing in which they sit in a chair that makes small movements and report their perception of motion. The investigators are currently looking for individuals who have had type 2 diabetes for at least 10 years.', 'detailedDescription': 'Previous studies have found that individuals with diabetes fall more frequently, have less stable posture, and have reduced motion and touch sensation in the lower extremities. This study will examine whether vestibular sensation is also affected by diabetes.\n\nThis study is observational because measurements will be made without the application of an intervention. The same measurement protocol was applied to a large group of normal subjects, and this published data will serve as normative controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes for at least 10 years\n* Under 250 pounds\n\nExclusion Criteria:\n\n* Medications not to be used include: Ambien (Zolpidem), Antivert, Bonine (Meclizine), Ativan (Lorazepam), Benadryl (diphenhydramine), Dalmane (Flurazepam), Dramamine, Doral (Quazepam), Fiorinal, Fiorcet (Butalbital), Halcion (Triazolam), Klonopin (Clonazepam), Librium, Librax (Chlordiazepoxide), Nembutal (Pentobarbital), Phenergan (Promethazine), Placidyl (Ethchlorvynol), Prosom (Estazolam), Restoril (Temazepam), Seconal (Secobarbital), Serax (Oxazepam), Transderm Scopes Patch, Vontrol (Diphenidol), Xanax (Alprazolam).\n* Individuals meeting the following criteria will be excluded: a) a history of head trauma, b) posterior fossa pathology, c) a well-defined otologic diagnosis (e.g., Benign Paroxysmal Positional Vertigo (BPPV), Meniere's disease, superior canal dehiscence, etc., unilateral or bilateral vestibular hypofunction) d) a recent history of seizures e) any other major neurologic (e.g., Parkinson's, Multiple Sclerosis, dementia, epilepsy, cerebellar ataxia, stroke, recent concussion, etc.) disorder, f) any major psychiatric (e.g., panic disorder, psychosis, etc.) disorder, and g) any other severe health problem (heart disease, pulmonary disease, cancer, etc.).\n* Due to nauseogenic nature of some motions and to protect fetus and mother, pregnant women will also be excluded from this study."}, 'identificationModule': {'nctId': 'NCT03380832', 'briefTitle': 'Motion Perception in Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Vestibular Perception and Action', 'orgStudyIdInfo': {'id': '196245'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 2 diabetes for at least 10 years', 'description': 'This is an observational study in which we will quantify vestibular thresholds in individuals who have had type 2 diabetes for at least 10 years. Normative data has recently been published and subjects with diabetes will be compared to a model that includes age effects.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Faisal Karmali', 'role': 'CONTACT', 'email': 'faisal_karmali@meei.harvard.edu', 'phone': '410-218-7614'}], 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Faisal Karmali, PhD', 'role': 'CONTACT', 'email': 'faisal_karmali@meei.harvard.edu', 'phone': '4102187614'}], 'overallOfficials': [{'name': 'Faisal Karmali, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Eye and Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Faisal_Karmali@MEEI.HARVARD.EDU', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}