Clinical Trials

Inclusion Criteria - ALS Participants:

• Age 18 years or older.
• Ability to understand the purpose and risks of the study, provide informed consent and comply with trial procedures.
• Diagnosis of ALS according to revised EEC, including suspected, possible, probable (+/- laboratory supported), and definite.
• Vital capacity (VC) at least 50% predicted value for gender, height and age at screening.
• In the opinion of the study physician, able to tolerate study procedures, including lumbar puncture, for the duration of the study.
• A Score of 2 or more on item one (SPEECH) of the ALSFRS-R scale.
• Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (i.e.: no bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).
• Access to a smartphone or tablet, and internet access at home.

Inclusion Criteria - Healthy Participants:

• Age 18 years or older.
• Capable of providing informed consent and complying with trial procedure.
• No history of neurological disease, as determined by the investigator.
• Individuals that harbor known genetic mutations that cause ALS yet are asymptomatic can also be enrolled in the Healthy participant cohort.
• Access to a smartphone or tablet, and internet access at home.

Exclusion Criteria:

• Any known or suspected abnormal CSF pressure or intracranial/intraspinal tumors.
• Use of anticoagulant medication (e.g., warfarin, dalteparin, enoxaparin, rivaroxaban, fondaparinux, dabigatran) that cannot be safely withheld until coagulation parameters have normalized prior to lumbar puncture and for up to a week following the lumbar puncture.
• Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
• Clinical judgment of the Site Investigator that the participant would be unable to undergo multiple lumbar punctures.
• Inability to perform at home speech measures using an app on a patient device (phone or iPad).
• Individuals participating in other clinical research studies will be eligible to participate in this study.  ALS patients on any currently approved therapies (riluzole, edaravone) are eligible to participate and continue their medications throughout this study.

Eligibility last updated 8/24/21. Questions regarding updates should be directed to the study team contact.