Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-06 @ 1:33 PM
Study NCT ID:
NCT02983305
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058499', 'term': 'Retinal Dystrophies'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080310', 'term': 'Smart Glasses'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'weisssar@umich.edu', 'phone': '734-936-7567', 'title': 'Sara', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 2-4 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Retinal Dystrophy', 'description': "Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Age-Matched Controls', 'description': "Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.", 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retinal Dystrophy', 'description': "Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}, {'id': 'OG001', 'title': 'Healthy Age-Matched Controls', 'description': "Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}], 'classes': [{'categories': [{'measurements': [{'value': '563.08', 'groupId': 'OG000', 'lowerLimit': '331.97', 'upperLimit': '715.60'}, {'value': '-3799.19', 'groupId': 'OG001', 'lowerLimit': '-4482.99', 'upperLimit': '-2598.07'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P \\< .05 was considered a priori to be statistically significant.', 'groupDescription': 'Test of equivalence of visual field area at baseline.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P \\< .05 was considered a priori to be statistically significant.', 'groupDescription': 'Test of equivalence of visual field area under intervention conditions.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.'}, {'pValue': '.003', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P \\< .05 was considered a priori to be statistically significant.', 'groupDescription': 'Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and two to four weeks', 'description': "Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.\n\nAverage of both eyes visual fields with intervention.", 'unitOfMeasure': 'degrees^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Gait Speed Compared to Baseline (Measured in Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retinal Dystrophy', 'description': "Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}, {'id': 'OG001', 'title': 'Healthy Age-Matched Controls', 'description': "Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}], 'classes': [{'categories': [{'measurements': [{'value': '-.01', 'groupId': 'OG000', 'lowerLimit': '-.05', 'upperLimit': '0.00'}, {'value': '-.01', 'groupId': 'OG001', 'lowerLimit': '-.05', 'upperLimit': '.05'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P \\< .05 was considered a priori to be statistically significant.', 'groupDescription': 'Test of equivalence of gait speed at baseline.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.'}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P \\< .05 was considered a priori to be statistically significant.', 'groupDescription': 'Test of equivalence of gait speed under intervention conditions.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.'}, {'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P \\< .05 was considered a priori to be statistically significant.', 'groupDescription': 'Comparison between study arms of the change in the gait speed detected between baseline and intervention.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and two to four weeks', 'description': "Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.\n\nAverage of data from both feet with intervention.", 'unitOfMeasure': 'meters per second', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Retinal Dystrophy', 'description': "Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}, {'id': 'FG001', 'title': 'Healthy Age-Matched Controls', 'description': "Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'comment': 'Participants were deemed to have not completed the study if they contributed incomplete data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'incomplete data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Retinal Dystrophy', 'description': "Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}, {'id': 'BG001', 'title': 'Healthy Age-Matched Controls', 'description': "Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.\n\nHead-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '37'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '23.5', 'upperLimit': '39.75'}, {'value': '33.5', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '39.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Visual Field Area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '568.96', 'groupId': 'BG000', 'lowerLimit': '232.40', 'upperLimit': '742.94'}, {'value': '19280.09', 'groupId': 'BG001', 'lowerLimit': '18441.30', 'upperLimit': '19388.97'}, {'value': '19009.42', 'groupId': 'BG002', 'lowerLimit': '12235.76', 'upperLimit': '19355.28'}]}]}], 'paramType': 'MEDIAN', 'description': 'Average of both eyes visual fields at baseline (no intervention).', 'unitOfMeasure': 'degrees^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gait Speed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.27', 'groupId': 'BG000', 'lowerLimit': '1.10', 'upperLimit': '1.31'}, {'value': '1.25', 'groupId': 'BG001', 'lowerLimit': '1.21', 'upperLimit': '1.42'}, {'value': '1.26', 'groupId': 'BG002', 'lowerLimit': '1.15', 'upperLimit': '1.32'}]}]}], 'paramType': 'MEDIAN', 'description': 'Average of both feet at baseline (no intervention).', 'unitOfMeasure': 'meters per second', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-15', 'size': 451536, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-23T10:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2016-11-04', 'resultsFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-20', 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)', 'timeFrame': 'Baseline and two to four weeks', 'description': "Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.\n\nAverage of both eyes visual fields with intervention."}], 'secondaryOutcomes': [{'measure': 'Change in Gait Speed Compared to Baseline (Measured in Seconds)', 'timeFrame': 'Baseline and two to four weeks', 'description': "Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.\n\nAverage of data from both feet with intervention."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Retinal Dystrophies', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to examine the ability of optical head-mounted display technology to enlarge the visual field of patients with severe visual field loss due to retinal dystrophy and to improve mobility and patient-reported outcomes.', 'detailedDescription': 'Worldwide it is estimated that 191 million people have moderate to severe visual impairment (MSVI) and an additional 32.4 million are blind. Patients with uncorrectable MSVI may undergo low vision rehabilitation (LVR), which has been shown to improve functional abilities, such as mobility. However, existing LVR strategies do not adequately address severe visual field constriction.\n\nIn this pilot study, the investigators will test the hypothesis that optical head-mounted display (HMD) technology expands constricted visual fields and improves mobility outcomes for patients with retinal dystrophy. We will use the Moverio HMD platform which is considered a non-significant risk device. Outcomes for patients with retinal dystrophy will be compared to normal age-matched controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for subjects with retinal dystrophy:\n\n* diagnosis of retinal dystrophy\n* severe vision loss that constitutes legal blindness\n* able to perform a reliable Goldmann visual field test\n* constricted visual field less than or equal to 20 degrees by Goldmann perimetry using the III4e stimulus in at least one eye with best-corrected visual acuity ≥ 20/60\n\nInclusion criteria for control subjects:\n\n* healthy controls\n* visit history with the Comprehensive and Pediatric Ophthalmology Services at the University of Michigan\n* able to perform a reliable Goldmann visual field test\n\nExclusion criteria for subjects with retinal dystrophy:\n\n* movement disorder that precludes evaluation of mobility\n* functional vision loss\n* pregnant women\n\nExclusion criteria for control subjects:\n\n* visually significant ocular condition other than correctable refractive error\n* movement disorder that precludes evaluation of mobility\n* functional vision loss\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02983305', 'briefTitle': 'Optical Head-Mounted Display Technology for Low Vision Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Optical Head-Mounted Display Technology for Low Vision Rehabilitation', 'orgStudyIdInfo': {'id': 'HUM00110408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retinal Dystrophy', 'description': 'Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.', 'interventionNames': ['Device: Head-Mounted Display']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Age-Matched Controls', 'description': 'Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.', 'interventionNames': ['Device: Head-Mounted Display']}], 'interventions': [{'name': 'Head-Mounted Display', 'type': 'DEVICE', 'otherNames': ['Epson Moverio'], 'description': "Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.", 'armGroupLabels': ['Healthy Age-Matched Controls', 'Retinal Dystrophy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kellogg Eye Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Joshua R Ehrlich, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joshua Ehrlich', 'investigatorAffiliation': 'University of Michigan'}}}}