Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment
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
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- FlowOx™
What it measured
Main measures
Self-Reported Spasticity, using Numerical Rating Scale:
4 weeks
Spasticity
Other measures (14)
Desire to continue treatment
4 weeks
Self-Reported Spasticity, using Numerical Rating Scale
3 months, 6 months
SpasticitySpasticity - modified Ashworth Scale
4 weeks, 3 months and 6 months
SpasticitySelf-reported pain using Numerical Rating Scale
4 weeks, 3 months and 6 months
SpasticityPainT25-FW
4 weeks, 3 months, 6 months
Disability progressionWalking and mobilityExpanded Disability Status Scale
4 weeks, 3 months, 6 months
Disability progressionSelf-reported sleep (NRS)
4 weeks, 3 months, 6 months
Mood and sleepHospital Anxiety and Depression Scale
4 weeks, 3 months, 6 months
Mood and sleepFatigue Scale for Motor and Cognitive Functions
4 weeks, 3 months, 6 months
Thinking and memoryFatigueMultiple Sclerosis Impact Scale (MSIS-29)
4 weeks, 3 months, 6 months
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 70 · EDSS 2.0 to 6.5
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
May 2021
Main results due
Sept 2022
Finished
Sept 2022