Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Scler… (NCT07193953) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)
Canada6 participantsStarted 2025-04-15
Plain-language summary
The goal of this study is to evaluate the safety and feasibility of IVIg administration in conjunction with primary motor cortex BBB opening using the Next Generation Dome Helmet (NGDH) FUS in adult participants with ALS.
Who can participate
Age range
18 Years
Sex
ALL
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 ALS as per the Gold Coast Criteria;
. Aged 18 years or older;
. Capable of providing informed consent and complying with study procedures;
. If taking Riluzole, on a stable dose for at least 4 weeks prior to Baseline;
. If taking Edaravone, on a stable dose of one completed cycle prior to Baseline;
. Respiratory Function Criterion:
. Able to communicate sensations during the Dome FUS procedure.
. Qualified fit for the anesthesia by an anesthesiologist, ASA I-III.
Exclusion criteria
. MRI findings:
. Active infection/inflammation
. Acute or chronic hemorrhages, specifically \> 4 lobar microbleeds, and no siderosis or macrohemorrhages
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of IVIg in patients with ALS
Timeframe: During and after IVIg administration at Week 0 and Week 2 Day 1 until Week 24.
2
Safety of DEFINITY® microbubbles
Timeframe: During and after DEFINITY® administration at Week 2 Day 1 until Week 24.
3
Feasibility of FUS BBB opening in the motor cortex
Timeframe: During and after Week 2 Day 1 FUS BBB opening until Week 24.
4
Safety of FUS BBB opening in the motor cortex
Timeframe: From up to 30 days before Week 0 to Week 24.