Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Active infection/inflammation
Acute or chronic hemorrhages, specifically > 4 lobar microbleeds, and no siderosis or macrohemorrhages
Tumor/space occupying lesion causing significant mass effect
Meningeal enhancement
Trial design
Treatments tested in this trial
- Next Generation Dome Helmet Focused Ultrasound
- Intravenous immunoglobulin (IVIG), 10% solution for infusion
- Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Sunnybrook Health Sciences Centre
Lead sponsor
Focused Ultrasound Foundation
Collaborator
Source ClinicalTrials.gov