Blood-Brain Barrier Opening Using MR-Guided Focused Ultrasound in Patients With Amyotrophic Later… (NCT03321487) | Clinical Trial Compass
CompletedNot Applicable
Blood-Brain Barrier Opening Using MR-Guided Focused Ultrasound in Patients With Amyotrophic Lateral Sclerosis
Canada4 participantsStarted 2018-04-13
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, and feasibility of Blood-Brain Barrier (BBB) opening using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent in patients with Amyotrophic Lateral Sclerosis (ALS).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria (Brooks et al. 2000).
✓. Right-hand dominant male or female aged 18 years or older.
✓. Capable of providing informed consent and complying with study procedures, including tolerability in the supine position and MRI examination without significant claustrophobia.
✓. If taking riluzole, on a stable dose for at least 30 days prior to Screening Visit.
✓. Slow Vital Capacity equal to or more than 50% predicted value for gender, height and age in the 30 days prior to the Screening Visit and able to lie supine without BiPAP.
✓. Severe left arm weakness and functional impairment, defined as Medical Research Council muscle strength score equals 3 or less in the index finger abduction and thumb abduction on the left side; OR severe left leg weakness and functional impairment, defined as Medical Research Council muscle strength score equals 3 or less at the hip flexors and ankle dorsiflexors on the left side.
✓. Able to communicate during the ExAblate® MRI-guided FUS procedure.
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.
What they're measuring
1
Safety - Device and Procedure related adverse events
Timeframe: At the time of the ExAblate MRgFUS procedure
✕. 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.