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Environmental Exposure and Neurological Diseases Questionnaire

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ClinicalTrials.gov Identifier: NCT02916966
Recruitment Status : Suspended (Research Quality & Safety Review)
First Posted : September 28, 2016
Last Update Posted : September 6, 2022
The Cleveland Clinic
Information provided by (Responsible Party):
Elijah W. Stommel, Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Patient Registry

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Case-control and Population Questionnaire Studying Environmental Risk Factors and Neurological Diseases
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Group/Cohort Intervention/treatment
ALS Patients in Case-Control
ALS patients enrolled by Cleveland Clinic Foundation (CCF)
Other: Patient Registry
Patient Registry

Non-neurodegenerative patients in case control
Non-neurodegenerative patients enrolled by CCF
Other: Patient Registry
Patient Registry

Non-neurodegeneration population in population control
Non-neurodegenerative general population enrolled by ABS mailing system from DHMC
Other: Patient Registry
Patient Registry

ALS Patients in State of OH
ALS registry of all cases in Ohio
Other: Patient Registry
Patient Registry

Primary Outcome Measures :
  1. Questionnaire for Environmental Exposures, Toxins, and Neurological Disease [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. ALS patients in case-control at CCF
  2. Non-neurodegenerative patients in case control at CCF
  3. Non-neurodegenerative general population in Ohio
  4. ALS patient registry in Ohio

Inclusion Criteria:

  • ALS
  • Non-neurodegenerative controls
  • Can willingly give consent
  • Over 18 years of age

Exclusion Criteria:

  • Cannot give consent
  • Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916966

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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
The Cleveland Clinic
Additional Information:

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Responsible Party: Elijah W. Stommel, Professor of Neurology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02916966    
Other Study ID Numbers: D06019
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases