Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity (FlowOx-MS)

Otivio

Status: Unknown

Conditions: Spasticity, Muscle; Multiple Sclerosis; Pain

Treatments: Device: FlowOx™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04904016

FO-NP001_29032021

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention FlowOx treatment

Experimental group

Description:

Each participating subject will be provided with one FlowOx™ system, which will be used about 1 hour per day every day of the week for a 4-week period with the option to extend the treatment time to up to 6 months if the patients would like to continue.

Treatment:

Device: FlowOx™