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Population-Based Ohio ALS Repository and ALS Risk Factors

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ClinicalTrials.gov Identifier: NCT02916966
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
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, and other environmental toxicants as risk factors for ALS. This work will advance the mission of the 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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Population-Based Ohio ALS Repository and a Case-Controlled Study of ALS Risk Factors
Actual Study Start Date : October 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019


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 ]


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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
Criteria

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


Contacts
Contact: Elijah W Stommel, MD, PhD 866-894-8131 neuroresearch@hitchcock.org
Contact: Tanya H Butt, MPH 603-650-6496 neuroresearch@hitchcock.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Erik Pioro, MD, PhD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
The Cleveland Clinic

Responsible Party: Elijah W. Stommel, Professor of Neurology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02916966     History of Changes
Other Study ID Numbers: D06019
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases