Recruiting PHASE1 INTERVENTIONAL 1-arm
NCT07193953
Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS) (ALSFUS003)
Targeting Neuroinflammation With Enhanced Delivery of Intravenous Immunoglobulin to the Motor Cortex Using Next Generation Dome Helmet Focused Ultrasound in Amyotrophic Lateral Sclerosis: A Phase I, Open Label Trial
Sponsor: Focused Ultrasound Foundation
Conditions
ALS Amyotrophic Lateral Sclerosis
Interventions
Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension Intravenous immunoglobulin (IVIG), 10% solution for infusion Next Generation Dome Helmet Focused Ultrasound
Updated 1 time since 2025 Last updated: Sep 18, 2025 Started: Apr 15, 2025 Primary completion: Nov 30, 2026 Completion: May 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.
A PHASE1 clinical study on ALS and Amyotrophic Lateral Sclerosis, this trial is actively recruiting participants. The trial is conducted by Focused Ultrasound Foundation and has accumulated 1 data snapshot since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
1 version recorded Recruiting — PHASE1
[monthly]
Eligibility Summary
No eligibility information available.
Contact Information
Sponsor contact:
- Focused Ultrasound Foundation
- Sunnybrook Health Sciences Centre
Data source: Sunnybrook Health Sciences Centre
For direct contact, visit the study record on ClinicalTrials.gov .