Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT02916966
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Environmental Exposure and Neurological Diseases Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire for Environmental Exposures, Toxins, and Neurological Disease', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. ALS patients in case-control at CCF\n2. Non-neurodegenerative patients in case control at CCF\n3. Non-neurodegenerative general population in Ohio\n4. ALS patient registry in Ohio', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALS\n* Non-neurodegenerative controls\n* Can willingly give consent\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Cannot give consent\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT02916966', 'acronym': 'Cleveland Ohio', 'briefTitle': 'Environmental Exposure and Neurological Diseases Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Case-control and Population Questionnaire Studying Environmental Risk Factors and Neurological Diseases', 'orgStudyIdInfo': {'id': 'D06019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALS Patients in Case-Control', 'description': 'ALS patients enrolled by Cleveland Clinic Foundation (CCF)', 'interventionNames': ['Other: Patient Registry']}, {'label': 'Non-neurodegenerative patients in case control', 'description': 'Non-neurodegenerative patients enrolled by CCF', 'interventionNames': ['Other: Patient Registry']}, {'label': 'Non-neurodegeneration population in population control', 'description': 'Non-neurodegenerative general population enrolled by ABS mailing system from DHMC', 'interventionNames': ['Other: Patient Registry']}, {'label': 'ALS Patients in State of OH', 'description': 'ALS registry of all cases in Ohio', 'interventionNames': ['Other: Patient Registry']}], 'interventions': [{'name': 'Patient Registry', 'type': 'OTHER', 'description': 'Patient Registry', 'armGroupLabels': ['ALS Patients in Case-Control', 'ALS Patients in State of OH', 'Non-neurodegeneration population in population control', 'Non-neurodegenerative patients in case control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Elijah W. Stommel', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}