Plain-English translation of NCT07193953 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing whether intravenous immunoglobulin (IVIG)—a treatment made from donated antibodies—can work better for ALS when delivered directly to the brain using focused ultrasound technology. A special helmet uses sound waves to temporarily open the barrier that normally prevents large molecules from entering the brain, allowing the medication to reach the motor cortex (the part of your brain that controls movement) more effectively. The study will follow 6 participants for 24 weeks to see if this approach is safe and how the body responds to it.
ALS damages the nerve cells that control movement, and current treatments have limited ability to reach the brain effectively. This trial explores whether using focused ultrasound to open the brain's protective barrier could allow this medication to work better by reaching the damaged motor cortex directly.
You will receive two doses of the immune therapy medication, with the second dose given about 2 weeks after the first. During the second dose, you'll undergo a procedure where you wear a special helmet that uses focused sound waves to temporarily open the blood-brain barrier, allowing the medication to reach your motor cortex more effectively. You'll need to visit the clinic multiple times over 24 weeks for assessments, including brain imaging and safety checks.
AI-generated summary from trial data · Jun 7, 2026 · Not medical advice
Canada