Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)

To be considered for this study, you would need to be an adult (18 or older) who has received an official diagnosis of ALS based on specific criteria. You also need to be able to understand the study information and agree to take part, as well as follow the study's instructions. If you are already taking certain ALS medications like Riluzole or Edaravone, your dose must have been stable for a certain period before joining.

Your breathing capacity is also important; you should be able to lie down flat without needing a special breathing machine or feeling uncomfortable. Alternatively, your lung function test results should show a certain level of capacity. It's also vital that you can communicate clearly during the treatment sessions with the special helmet.

There are also reasons why you might not be able to join. For example, if MRI scans of your brain show certain issues like infections, specific types of bleeding, or tumours. Other reasons include having too many scars or skin conditions on your scalp where the helmet would be placed, or having certain metal implants in your head. Significant heart problems or uncontrolled high blood pressure would also prevent participation, as would having a pacemaker or certain blood vessel issues in your heart.

If you decide to take part, you would be one of six participants in total. You would attend several visits over about 24 weeks (around 6 months). Initially, you'll receive the first dose of IVIG. About two weeks later, you'll receive a second dose of IVIG, and at the same time, you'll undergo the special procedure using the Next Generation Dome Helmet with focused sound waves and tiny bubbles to help the IVIG reach your brain. This helmet treatment targets specific areas in both halves of your brain involved in movement.

Throughout the study, you would have regular check-ups to monitor your health, how you're feeling, and to look for any side effects. Researchers will also be checking how the treatment affects your body and how the drug is handled by your system. There are two groups in the study, with each group of three participants receiving a different dose of IVIG – either 0.4g/kg or 0.8g/kg, split into two doses. All follow-up visits will continue for 24 weeks from your first treatment.