Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT01911312
Status:
UNKNOWN
Last Update Posted:
2013-07-30
First Post:
2013-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Thermal-Aided Muscle Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001247', 'term': 'Asthenia'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-26', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Contraction Force', 'timeFrame': 'At 30 s intervals for 20 minutes', 'description': 'Measured in Newtons'}]}, 'conditionsModule': {'conditions': ['Weakness', 'Atrophy']}, 'descriptionModule': {'briefSummary': 'An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject does not meet any exclusion criteria\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Subject is pregnant\n* Subject has an implanted pacemaker/defibrillator\n* Subject diagnosed with epilepsy\n* Subject has implanted metallic femoral rods\n* Subject is chair- or bed-bound\n* Subject has neuromuscular disease or abnormalities\n* Subject BMI \\> 45\n* Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study'}, 'identificationModule': {'nctId': 'NCT01911312', 'briefTitle': 'Evaluation of Thermal-Aided Muscle Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Niveus Medical, Inc.'}, 'orgStudyIdInfo': {'id': 'CLP3.00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Device: Thermal-aided muscle stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Body Temperature Control', 'description': 'Stimulation performed with body temperature control', 'interventionNames': ['Device: Body Temperature Stimulation']}], 'interventions': [{'name': 'Thermal-aided muscle stimulation', 'type': 'DEVICE', 'description': 'Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110', 'armGroupLabels': ['Intervention']}, {'name': 'Body Temperature Stimulation', 'type': 'DEVICE', 'description': 'Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110', 'armGroupLabels': ['Body Temperature Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bahman Nouri, MD', 'role': 'CONTACT', 'phone': '650-962-4690'}, {'name': 'Bahman Nouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Melchor Pavilion', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'centralContacts': [{'name': 'Brian Fahey, PhD', 'role': 'CONTACT', 'email': 'brian@niveusmedical.com', 'phone': '650-336-7922'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niveus Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}