Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 4:31 PM
Study NCT ID:
NCT05535257
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2022-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'langley.suzanne@mayo.edu', 'phone': '9044724288', 'title': 'Suzanne Langley OTR/L', 'organization': 'Mayo Clinic Florida'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was collected during the wearing trial (4 hours) of each subjects participation from dates 9/27/2022 to 11/14/2023', 'eventGroups': [{'id': 'EG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Stroke patients with UE weakness and or sensory impairments.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Number of subjects who answered yes to the question "Are you tolerating this sleeve"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain With SCD Sleeve and Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Pain outcome measure on 20 subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Total number of subjects to report No pain measured by Visual Analogue Scale (VAS) where patient identifies pain on a line between "no pain" and "worst possible pain".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Nail Bed Color', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Nail bed color (normal, blue, dusky)'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Bluish', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Dusky', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Edema Measured in Inches of Circumference of Forearm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Edema on UE forearm upper 2/3 below cubital fossa'}], 'classes': [{'title': '1.5 inch decrease in circumference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '1.25 inch decrease in circumference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '1 inch decrease in circumference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '.5 inch decrease in circumference', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '.25 inch decrease in circumference', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'No change in circumference', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '.25 inch increase in circumference', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UE Strength Using Motor Arm Subsection #5 of NIH Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'UE Strength using Motor Arm subsection #5 of NIH scale'}], 'classes': [{'categories': [{'title': '4 (no movement)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '3 (no effort against gravity)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '2 (some effort against gravity)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '1 (drift)', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': '0 (no drift)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'The limb is placed in the appropriate position: extend the arm (palm down) 90 degrees if sitting or 45 degrees if supine. Drift is scored if the arm falls before 10 seconds. Documenting using Scale definition: 0=No drift, 1=Drift, 2=Some effort against gravity, 3=No effort against gravity; limb falls, 4=No movement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UE Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'UE Sensation'}], 'classes': [{'categories': [{'title': 'Sensation Intact', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Sensation Impaired', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Using cotton swab and lightly touching skin at dermatome points C2, C3, C4, C5, C6, C7, C8, T1, T2 using the International Standards for the Classification of Spinal Cord Injury Key Sensory Points documenting "Intact" or "Impaired"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UE Skin Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'UE Skin Integrity'}], 'classes': [{'categories': [{'title': 'Intact Skin Integrity', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Impaired Skin Integrity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Prior to placement of sleeve and upon removal of sleeve during check time skin will be visually assessed and the terms "Intact" or "Impaired" will be documented. Any new "redness", "rash", or "bruising" and "area" of arm will be documented and the need to remove sleeve at that time will be determined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UE Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'UE hand/grip strength measured in pounds using dynamometer to affected hand only'}], 'classes': [{'categories': [{'title': '0 lbs baseline and 0 at 4 hours', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '30 lbs at baseline and 34 lbs at 4 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '12 lbs at baseline and 10 lbs at 4 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '65 lbs at baseline and 62 lbs at 4 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '35 lbs at baseline and 35 lbs at 4 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '20 lbs at baseline and 2 lbs at 4 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '32 lbs at baseline and 38 lbs at 4 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and at four-hours for each subject', 'description': 'Using dynamometer in pounds measures affected hand strength at baseline and at 4-hours for each subject. This outcome measure was added approximately 1/2 way through the subject recruitment as a revision to this study to help capture subjects with hand weakness who may not have gross arm weakness (captured by Motor arm Subsection #5 outcome measure).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Subjects post stroke with upper extremity weakness and impaired sensation have the SCD sleeve placed on the arm for up to 4 hours for one day only\n\nSequential Compression Device: Calf size lower extremity sequential compression device sleeve will be placed on the weak upper extremity blow the cubital fossa and may include the hand if necessary. The device will inflate and deflate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period for 20 subjects enrolled in this study was from 9/27/2022 to 11/14/2023. All subjects were recruited and enrolled in the Mayo Clinic Hospital setting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequential Compression Device (SCD) on Upper Extremity', 'description': 'Subjects post stroke with upper extremity weakness had the SCD sleeve placed on the arm for up to 4 hours for one day only Device: Sequential Compression Device Calf size lower extremity sequential compression device sleeve was placed on the weak upper extremity blow the cubital fossa and may include the hand if necessary. The device inflated and deflated,\n\nOther Names:\n\nSCD'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-10-10', 'size': 341501, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-14T20:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2022-08-19', 'resultsFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-05', 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nail Bed Color', 'timeFrame': '4 hours', 'description': 'Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color'}, {'measure': 'Edema Measured in Inches of Circumference of Forearm', 'timeFrame': '4 hours', 'description': 'Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.'}, {'measure': 'UE Strength Using Motor Arm Subsection #5 of NIH Scale', 'timeFrame': '4 hours', 'description': 'The limb is placed in the appropriate position: extend the arm (palm down) 90 degrees if sitting or 45 degrees if supine. Drift is scored if the arm falls before 10 seconds. Documenting using Scale definition: 0=No drift, 1=Drift, 2=Some effort against gravity, 3=No effort against gravity; limb falls, 4=No movement'}, {'measure': 'UE Sensation', 'timeFrame': '4 hours', 'description': 'Using cotton swab and lightly touching skin at dermatome points C2, C3, C4, C5, C6, C7, C8, T1, T2 using the International Standards for the Classification of Spinal Cord Injury Key Sensory Points documenting "Intact" or "Impaired"'}, {'measure': 'UE Skin Integrity', 'timeFrame': '4 hours', 'description': 'Prior to placement of sleeve and upon removal of sleeve during check time skin will be visually assessed and the terms "Intact" or "Impaired" will be documented. Any new "redness", "rash", or "bruising" and "area" of arm will be documented and the need to remove sleeve at that time will be determined.'}, {'measure': 'UE Grip Strength', 'timeFrame': 'Baseline and at four-hours for each subject', 'description': 'Using dynamometer in pounds measures affected hand strength at baseline and at 4-hours for each subject. This outcome measure was added approximately 1/2 way through the subject recruitment as a revision to this study to help capture subjects with hand weakness who may not have gross arm weakness (captured by Motor arm Subsection #5 outcome measure).'}], 'primaryOutcomes': [{'measure': 'Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.', 'timeFrame': '4 hours', 'description': 'Number of subjects who answered yes to the question "Are you tolerating this sleeve"'}], 'secondaryOutcomes': [{'measure': 'Pain With SCD Sleeve and Device', 'timeFrame': '4 hours', 'description': 'Total number of subjects to report No pain measured by Visual Analogue Scale (VAS) where patient identifies pain on a line between "no pain" and "worst possible pain".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Upper Extremity Weakness', 'Stroke']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to establish that application of a Sequential Compression Device (SCD) and lower extremity (LE) sleeve applied to a hemi-paretic upper extremity is safe.', 'detailedDescription': 'Studies has shown that passively stimulating the arm with vibration can improve sensory and motor recovery and movement. Researchers want to expand on this with a more advanced stimulation but in a device that is already routinely used. The SCD is normally used to prevent blood clots. It uses pressure to keep blood moving in the leg. It is routinely used in hospitals across the country. While it does this it warms and even vibrates the leg giving many types of stimulation to the limb and to the brain. This stimulation may help improve recovery further, at marginal cost, while possibly reducing the chances of blood clots in an immobile limb.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to Mayo Clinic/Jacksonville, post-stroke with a hemiparetic upper extremity.\n* Able to provide consent of participation by self-agreement.\n* Patients with a hemiparetic upper extremity will be determined using the NIH Motor Arm subsection from the NIH scale and score a 1-4.\n* Patients who have received thrombolytic therapeutic medicine \\> 13 hours (per site specific policy) will not be excluded from inclusion in this study.\n* Patients who score \\> 13 on the BIMS to ensure intact cognition.\n\nExclusion Criteria:\n\n* Inability to provide consent of participation.\n* Subjects with aphasia or the inability to effectively communicate their pain consistently.\n* Questionable reliability scoring \\< 13 on the BIMS, has an existing invasive line (PICC line, IV, AV fistula or AV graft); recent surgery or vein ligation in the involved extremity.\n* Recent skin graft in the involved extremity.\n* Confirmed DVT in the affected.\n* Upper extremity including axillary or subclavian veins; open or active wounds or infection in the involved extremity.\n* Upper extremity ischemia, gangrene, cellulitis or severe arteriosclerosis in the affected upper extremity.\n* Status-post axillary lymph node dissection on the involved side; congestive heart failure (CHF) acute exacerbation; acute edema of unknown etiology in the involved upper extremity.\n* Subjects with extreme deformity of the affected upper extremity.\n* Subjects with an acute kidney injury.\n* Subjects who are hemodynamically unstable 1,7,17.\n* Patients who have received thrombolytic therapeutic medicine administered \\< 13 hours (per site specific policy) prior to application of SCD sleeve.'}, 'identificationModule': {'nctId': 'NCT05535257', 'briefTitle': 'A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study to Establish Use of Lower Extremity Sleeve and Sequential Compression Pump Device in Patients With Upper Extremity Weakness Post-Stroke', 'orgStudyIdInfo': {'id': '21-009068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential Compression Device (SCD) on upper extremity', 'description': 'Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only', 'interventionNames': ['Device: Sequential Compression Device']}], 'interventions': [{'name': 'Sequential Compression Device', 'type': 'DEVICE', 'otherNames': ['SCD'], 'description': 'Calf size lower extremity sequential compression device sleeve will be placed on the weak upper extremity blow the cubital fossa and may include the hand if necessary. The device will inflate and deflate.', 'armGroupLabels': ['Sequential Compression Device (SCD) on upper extremity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32259', 'city': 'Saint Johns', 'state': 'Florida', 'country': 'United States', 'facility': 'C Joseph Yelvington'}], 'overallOfficials': [{'name': 'Suzanne Langley, OT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suzanne K. Langley', 'investigatorAffiliation': 'Mayo Clinic'}}}}