Table 1.

Inclusion/Exclusion Criteria for the Brave Dreams Trial.

Inclusion criteria

Adults 18 to 65 years old

Subjects with multiple sclerosis (MS) affected by CCSVI screened with echo-Doppler according to a consensus protocol

Relapsing/remitting and\or secondary/progressive MS

Expanded Disability Status Scale 2–5.5

Disease duration ≤15 years

Care provided by the recruiting center for at least 2 years

No relapse in the 30 days preceding the procedure

Clinical stability in the last 6 months with disease modification treatments

Subjects under the best available therapy

Exclusion criteria

Previous treatment for CCSVI or involvement in other clinical trials in the prior 3 months

Under treatment with fingolimod, cladribine, laquinimod, or botulinum toxin or had infusion pump or neurostimulator implantation

Pregnant or refusing to adopt contraception

Presence of significant comorbidities

Alcohol or drug abuse

Thrombophilia

Contraindication to magnetic resonance imaging