SHS_543099 ELLM FIRO 16024
A study to evaluate the sensitivity, specificity, and overall accuracy of an amyotrophic lateral sclerosis diagnostic test developed by Iron Horse Diagnostics, Inc.
The primary objective of the study is to determine the sensitivity, specificity, and overall accuracy of a CSF-based test for ALS diagnosis.
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.
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.
Willingness and medical ability to comply with scheduled visits, LP for CSF collection, laboratory tests, and other study procedures.
Any contraindications to having a lumbar puncture (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 r 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.
Amyotrophic lateral sclerosis
Michael Elliott, M.D.
Iron Horse Diagnostics