Clinical trial NCT04904016: Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Spasticity, Muscle
Pain
Keywords: Blood flow
FlowOx™
Stiffness
Lead sponsor: Otivio AS
Sponsor class: INDUSTRY
Collaborators: name: Haukeland University Hospital
First posted: 2021-05-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Self-Reported Spasticity, using Numerical Rating Scale:
timeFrame: 4 weeks
Secondary outcomes:
measure: Desire to continue treatment
timeFrame: 4 weeks
measure: Self-Reported Spasticity, using Numerical Rating Scale
timeFrame: 3 months, 6 months
measure: Spasticity - modified Ashworth Scale
timeFrame: 4 weeks, 3 months and 6 months
measure: Self-reported pain using Numerical Rating Scale
timeFrame: 4 weeks, 3 months and 6 months
measure: T25-FW
timeFrame: 4 weeks, 3 months, 6 months
measure: Expanded Disability Status Scale
timeFrame: 4 weeks, 3 months, 6 months
measure: Self-reported sleep (NRS)
timeFrame: 4 weeks, 3 months, 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 4 weeks, 3 months, 6 months
measure: Fatigue Scale for Motor and Cognitive Functions
timeFrame: 4 weeks, 3 months, 6 months
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 4 weeks, 3 months, 6 months
measure: SDMT
timeFrame: 4 weeks, 3 months, 6 months
measure: Change in medication
timeFrame: 4 weeks, 3 months and 6 monhts
measure: Compliance
timeFrame: 4 weeks, 3 months, 6 months
measure: Safety- Incidence of device related adverse and serious adverse events
timeFrame: 4 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Neuro-SysMed, Dept. of Neurology, Haukeland University Hospital, & Dept. of Clinical Medicine, University of Bergen
Study officials:
affiliation: Neuro-SysMed, Haukeland University Hospital, Bergen Norway
name: Kjell-Morten Myhr
role: PRINCIPAL_INVESTIGATOR
References: