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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Otivio AS
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Self-Reported Spasticity, using Numerical Rating Scale:
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnose MS according to revised McDonald criteria
- •Give written informed consent.
- •Have an age between 18-70 years.
- •Have stable disease without attack or progression of loss of function in the last three months.
- •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
- •Have tried standard treatment for spasticity and pain without achieving a satisfactory effect.
- •Stable and unchanged treatment of spasticity and pain the last month
- •Stable and unchanged disease-modulating treatment for MS last 6 months.
- •Function level measured by the Expanded Disability Status Scale (EDSS) 2.0-6.5
- •Can self-manage study equipment.
Exclusion Criteria
- •Have spasticity due to a disease other than MS.
- •Pregnancy or plan a pregnancy within the upcoming study period of 6 months.
- •Have an ongoing infection.
- •Have received botulinum toxin injection for spasticity within the last 4 months.
- •Have symptoms or illness that make it difficult to participate in the study.
- •Having planned surgery or other treatment within the coming study period of 6 months makes it difficult to participate in the study.
- •Have functional scores outside inclusion criteria measured by EDSS 2.0-6.5
- •Have had disease activity beyond requirements for stable disease as described in inclusion criteria
- •Have changed drug treatment beyond requirements for stable treatment as described in inclusion criteria.
Outcomes
Primary Outcomes
Self-Reported Spasticity, using Numerical Rating Scale:
Time Frame: 4 weeks
The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher scores mean a worse outcome. To evaluate change in self-reported spasticity using the numerical rating scale (NRS) over the last 24 hours after daily 1-hour self-treatment with FlowOx from baseline to week 4
Secondary Outcomes
- Spasticity - modified Ashworth Scale(4 weeks, 3 months and 6 months)
- T25-FW(4 weeks, 3 months, 6 months)
- SDMT(4 weeks, 3 months, 6 months)
- Self-reported pain using Numerical Rating Scale(4 weeks, 3 months and 6 months)
- Expanded Disability Status Scale(4 weeks, 3 months, 6 months)
- Self-reported sleep (NRS)(4 weeks, 3 months, 6 months)
- Change in medication(4 weeks, 3 months and 6 monhts)
- Hospital Anxiety and Depression Scale(4 weeks, 3 months, 6 months)
- Compliance(4 weeks, 3 months, 6 months)
- Safety- Incidence of device related adverse and serious adverse events(4 weeks, 3 months, 6 months)
- Desire to continue treatment(4 weeks)
- Self-Reported Spasticity, using Numerical Rating Scale(3 months, 6 months)
- Fatigue Scale for Motor and Cognitive Functions(4 weeks, 3 months, 6 months)
- Multiple Sclerosis Impact Scale (MSIS-29)(4 weeks, 3 months, 6 months)