A Study to Evaluate the Performance of a Diagnostic Test for Amyotrophic Lateral Sclerosis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 14-006742
NCT ID: NCT02759913
Sponsor Protocol Number: IronHorseDx001
About this study
The purpose of this study is to determine the overall accuracy of a cerebro-spinal fluid (CSF) based test for the diagnosis of amyotrophic lateral sclerosis (ALS) or another neurodegenerative diseases, including spinal cord diseases, muscle diseases and neurological diseases such as multiple sclerosis, multifocal motor neuropathy, myasthenia gravis and spinal muscular atrophy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Must meet the following eligibility criteria at the screening visit
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Aged 21 to 80 years old, inclusive
- Willingness and medical ability to comply with scheduled visits, LP for CSF collection, laboratory tests, and other study procedures
- Must meet one of the following
- Recent diagnosis of sporadic or familial ALS (within 18 months of first visit for ALS symptoms) according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998 [Brooks 1999] )
- Recent diagnosis of neuromuscular disease other than ALS (within 12 months of first visit for neurologic symptoms)
- Undergoing diagnostic procedures for neuromuscular disease
Exclusion Criteria
- Must not have any of the following criteria at the screening visit
- Any contraindications to having an LP, including but not limited to
- Platelet count <100,000/µL
- History of bleeding disorder
- Use of platelet antiaggregant or anticoagulant drugs, including but not limited to clopidogrel, dipyridamole, ticlopidine , and warfarin
- Use of aspirin at a prophylactic dose of 75-325 mg or less is acceptable
- History of intolerance to the LP procedure
- Evidence of topical or other skin infection at the LP site
- Prior spinal fusion surgery or other spinal surgery at the LP site
- If undergoing skin biopsy, evidence of topical or other skin infection at the biopsy site
- History of allergy or other adverse reaction to local anesthetics used in the study
- History of traumatic central nervous system injury or stroke
- History of chronic liver or renal failure
- Requirement for artificial respiration, including tracheostomy and any use of bilevel positive airway pressure (BiPAP) therapy
- Female subjects who are pregnant or currently breastfeeding
- Current enrollment in any other investigational drug, medical devices, or disease study
- Other unspecified reasons that in the opinion of the Investigator or Iron Horse make the subject unsuitable for enrollment
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mark Ross, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available