Blood-Brain Barrier Opening Using MR-Guided Focused Ultrasound in Patients With Amyotrophic Lateral Sclerosis

Exclusion criteria

• . Unable to complete high-density CT and MRI studies of the head at the Screening Visit or any other MRI contraindication, such as:
• . MRI findings:
• . More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
• . Clips or other metallic implanted objects in the skull or the brain, except shunts.
• . Significant cardiac disease or unstable hemodynamic status including:
• . Uncontrolled hypertension (systolic \> 150 or diastolic BP \> 100 on medication).
• . On medications that increase the bleeding risk, specifically: a) aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abciximab) for the last 7 days prior to treatment; b) oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours, and intravenous or subcutaneous heparin-derived compounds for the last 48 hours.
• . History of a bleeding disorder, coagulopathy or a history of spontaneous hemorrhage.