Viewing Study NCT00674934


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Study NCT ID: NCT00674934
Status: UNKNOWN
Last Update Posted: 2009-01-05
First Post: 2008-05-06
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Far Infrared Irradiation for Managing and Treating Multiple Sclerosis (MS)
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-02', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2009-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment of MS', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Rehabilitation of MS Patients', 'timeFrame': '2 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MS (Multiple Sclerosis)', 'Multiple Sclerosis, Acute Fulminating', 'Sclerosis, Disseminated'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (abbreviated MS) is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. This study will investigate the use of far infrared radiation for MS control, management and treatment.', 'detailedDescription': 'MS a demyelinating disease, is any disease of the nervous system in which the myelin sheath of neurons is damaged. This impairs the conduction of signals in the affected nerves, causing impairment in sensation, movement, cognition, or other functions depending on which nerves are involved.\n\nMS affects the areas of the brain and spinal cord known as the white matter. White matter cells carry signals between the grey matter areas, where the processing is done, and the rest of the body. More specifically, MS destroys oligodendrocytes which are the cells responsible for creating and maintaining a fatty layer, known as the myelin sheath, which helps the neurons carry electrical signals.\n\nObservations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.\n\nIt is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with MS\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00674934', 'briefTitle': 'Far Infrared Irradiation for Managing and Treating Multiple Sclerosis (MS)', 'organization': {'class': 'OTHER', 'fullName': 'GAAD Medical Research Institute Inc.'}, 'officialTitle': 'Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'GAAD-MS-CTP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Radiation', 'interventionNames': ['Radiation: Far Infrared Radiation (5μm to 20μm wavelength)']}], 'interventions': [{'name': 'Far Infrared Radiation (5μm to 20μm wavelength)', 'type': 'RADIATION', 'otherNames': ['Far Infrared Radiation'], 'description': 'Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4V 1L5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Centre for Incurable Diseases', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ken Nedd, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GAAD Medical Research Institute Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GAAD Medical Research Institute Inc.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Kwasi Donyina/Founder & President', 'oldOrganization': 'GAAD Medical Research Institute Inc.'}}}}