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Focused Ultrasound
Blood-Brain Barrier opening with MRgFUS for Amyotrophic Lateral Sclerosis
N/A
Waitlist Available
Led By Lorne Zinman, MD
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of the exablate mrgfus procedure
Awards & highlights
Study Summary
This trial will test whether it is safe to open the blood-brain barrier using MRI-guided focused ultrasound in order to improve treatment for ALS.
Eligible Conditions
- Amyotrophic Lateral Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of the exablate mrgfus procedure and 24 hours post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of the exablate mrgfus procedure and 24 hours post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety - Device and Procedure related adverse events
Secondary outcome measures
Degree of contrast enhancement seen on post-procedure MRI
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage II CohortExperimental Treatment1 Intervention
Blood-Brain Barrier opening with MRgFUS. BBB opening of a larger volume of the primary motor cortex
Group II: Stage I CohortExperimental Treatment1 Intervention
Blood-Brain Barrier opening with MRgFUS. BBB opening of a small volume of the primary motor cortex
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Who is running the clinical trial?
InSightecLead Sponsor
89 Previous Clinical Trials
3,706 Total Patients Enrolled
Lorne Zinman, MDPrincipal InvestigatorMedical Director, ALS/Neuromuscular Clinic, Sunnybrook Health Sciences Centre
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