Environmental Exposure and Neurological Diseases Questionnaire

Case-control and Population Questionnaire Studying Environmental Risk Factors and Neurological Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: Patient Registry

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Elijah W Stommel, MD, PhD; Phone Number: 866-894-8131; Email: neuroresearch@hitchcock.org
• Study Contact Backup: Name: Kathleen Sullivan; Phone Number: (603) 650-6496; Email: neuroresearch@hitchcock.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Erik Pioro, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Questionnaire for Environmental Exposures, Toxins, and Neurological Disease	1 year

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimated): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Nervous System Diseases
• Other Study ID Numbers: D06019