SOD1 Kinetics Measurements in ALS Patients

Korábbi kezelés

• Use of anticoagulant medication (eg. 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.

Más betegség

• Medically unable to undergo lumbar puncture (LP) as determined by the investigator (i.e.,bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).
• Any active dermatologic disease.
• Any connective tissue disease including systemic lupus erythematous, Sjögren's syndrome, scleroderma or mixed connective tissue disease.
• Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
• Allergy to Lidocaine

Laborértékek

• Safety lab values greater than 2X the upper limit of normal

Egyéb

• Invasive ventilator dependence, such as tracheostomy
• Any known or suspected abnormal CSF pressure or intracranial/intraspinal tumors.
• Clinical judgment of the Site Investigator that the subject would be unable to undergo multiple lumbar punctures.
• Pregnancy
• Any contraindication for lumbar puncture

• Males or females of any race aged 18 or older
• Positive for SOD1 mutation (SOD1 ALS only)
• Diagnosed with Definite, Probable or Possible ALS in accordance with El Escorial criteria (ALS and SOD1 Positive ALS only)
• Able to hold position and breathe comfortably for the duration of the LP procedure as determined by the LP physician or Nurse Practitioner
• Subjects must be able to provide informed consent