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Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
Sponsor: Otivio AS
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2021-05-28
Completion Date
2022-09-30
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
FlowOx™
The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot.
Locations (1)
Neuro-SysMed, Dept. of Neurology, Haukeland University Hospital, & Dept. of Clinical Medicine, University of Bergen
Bergen, Norway