Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain

Brief Summary

This study is based on a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS) (NCT05562453). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period (NCT05562453), all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part. The participants who volunteer to continue in the 6-months optional extension part will be included in this study.