Status:
UNKNOWN
Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
Lead Sponsor:
Otivio AS
Collaborating Sponsors:
Haukeland University Hospital
Conditions:
Multiple Sclerosis
Spasticity, Muscle
Eligibility:
All Genders
18-70 years
Phase:
NA
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 targ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04904016
Start Date
May 28 2021
End Date
December 1 2021
Last Update
May 27 2021
Active Locations (1)
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1
Neuro-SysMed, Dept. of Neurology, Haukeland University Hospital, & Dept. of Clinical Medicine, University of Bergen
Bergen, Norway, 5021