Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity

A Single Center, Open, Non-controlled Pilot Investigation to Evaluate FLowOx2.0™ for Experimental Treatment of Spasticity With Concomitant Pain in Multiple Sclerosis, Using Intermittent Negative Pressure Affecting Arteriovenous Reflex

This is a descriptive, prospective, non-controlled clinical investigation to be conducted on approximately 10 enrolled subjects at one site at Haukeland University Hospital in Bergen, Norway. The target subjects are male or female, 18-70 years, diagnosed with MS according to revised McDonald criteria (9) with spasticity and pain associated with the spasticity. Spasticity is evaluated based on self-reported spasticity using the numerical rating scale (NRS) which describes the average score of spasticity over the last 24 hours at >4 (where the scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst possible spasticity), - combined with pain in the lower extremities last 24 hours. The pilot investigation is done to evaluate if FlowOx2.0™ can be used to treat spasticity with concomitant pain in patients with multiple sclerosis, using intermittent negative pressure affecting arteriovenous reflex.

Inclusion Criteria:

1. Diagnose MS according to revised McDonald criteria
2. Give written informed consent.
3. Have an age between 18-70 years.
4. Have stable disease without attack or progression of loss of function in the last three months.
5. Have self-reported spasticity, scored using the numeric rating scale (NRS) which describes the average score of spasticity over the last 24 hours, at ≥ 4 (where the scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst possible spasticity), - combined with pain in the lower extremities last 24 hours
6. Have tried standard treatment for spasticity and pain without achieving a satisfactory effect.
7. Stable and unchanged treatment of spasticity and pain the last month
8. Stable and unchanged disease-modulating treatment for MS last 6 months.
9. Function level measured by the Expanded Disability Status Scale (EDSS) 2.0-6.5
10. Can self-manage study equipment.

Exclusion Criteria:

1. Have spasticity due to a disease other than MS.
2. Pregnancy or plan a pregnancy within the upcoming study period of 6 months.
3. Have an ongoing infection.
4. Have received botulinum toxin injection for spasticity within the last 4 months.
5. Have symptoms or illness that make it difficult to participate in the study.
6. Having planned surgery or other treatment within the coming study period of 6 months makes it difficult to participate in the study.
7. Have functional scores outside inclusion criteria measured by EDSS 2.0-6.5
8. Have had disease activity beyond requirements for stable disease as described in inclusion criteria
9. Have changed drug treatment beyond requirements for stable treatment as described in inclusion criteria.