Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01093027
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2010-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014202', 'term': 'Tremor'}, {'id': 'D020329', 'term': 'Essential Tremor'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'evidente.virgilio@mayo.edu', 'phone': '480-301-8000', 'title': 'Virgilio Evidente MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '15 - 30', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '30 - 15', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tremor Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - 30', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.'}, {'id': 'OG001', 'title': '30 - 15', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.'}], 'classes': [{'title': 'Visit 1', 'categories': [{'measurements': [{'value': '127', 'spread': '50', 'groupId': 'OG000'}, {'value': '104', 'spread': '44', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '150', 'spread': '73', 'groupId': 'OG000'}, {'value': '100', 'spread': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 10 minutes of limb cooling treatment.', 'description': 'Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.', 'unitOfMeasure': 'cm/s^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tremor Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '15 - 30', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.'}, {'id': 'OG001', 'title': '30 - 15', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.'}], 'classes': [{'title': 'Visit 1', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 10 minutes of limb cooling treatment.', 'description': 'Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '15 - 30', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.'}, {'id': 'FG001', 'title': '30 - 15', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.'}], 'periods': [{'title': 'Visit 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Visit 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Visits were scheduled between June 2010 and December 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '15 - 30', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.'}, {'id': 'BG001', 'title': '30 - 15', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '76.3', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '73.8', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2010-03-24', 'resultsFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-06', 'studyFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tremor Amplitude', 'timeFrame': 'After 10 minutes of limb cooling treatment.', 'description': 'Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.'}], 'secondaryOutcomes': [{'measure': 'Tremor Rating Scale', 'timeFrame': 'After 10 minutes of limb cooling treatment.', 'description': 'Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Essential Tremor', 'Cooling', 'Temperature', 'Patients with Essential Tremor involving the upper limbs with at least moderate tremor.'], 'conditions': ['Tremor']}, 'descriptionModule': {'briefSummary': 'To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor using a more practical method of limb cooling through a forearm cold pack.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with clinical diagnosis of E.T. for at least a year by a movement disorder neurologist\n* A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand\n* Ages 18 to 95 years old\n\nExclusion Criteria:\n\n* (+) sensory loss in the upper extremities\n* dermatologic lesions in upper extremities (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash)\n* known history of sensitivity to cold (i.e., cold urticaria)\n* known peripheral vascular disease\n* Raynaud's phenomenon\n* scleroderma"}, 'identificationModule': {'nctId': 'NCT01093027', 'briefTitle': 'Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor', 'orgStudyIdInfo': {'id': '09-007889'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '15 - 30', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.', 'interventionNames': ['Other: 15 - 30']}, {'type': 'OTHER', 'label': '30 - 15', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.', 'interventionNames': ['Other: 30 - 15']}], 'interventions': [{'name': '15 - 30', 'type': 'OTHER', 'description': 'The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.', 'armGroupLabels': ['15 - 30']}, {'name': '30 - 15', 'type': 'OTHER', 'description': 'The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.', 'armGroupLabels': ['30 - 15']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Virgilio Evidente, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Virgilio Evidente, MD', 'oldOrganization': 'Mayo Clinic'}}}}