Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity

NCT ID: NCT04904016

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2021-12-31

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.

Conditions

Multiple Sclerosis; Spasticity, Muscle; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention FlowOx treatment

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.

Group Type: EXPERIMENTAL

FlowOx™

Intervention Type: DEVICE

The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot.

Interventions

FlowOx™

The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Otivio AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kjell-Morten Myhr

Role: PRINCIPAL_INVESTIGATOR

Neuro-SysMed, Haukeland University Hospital, Bergen Norway

Locations

Neuro-SysMed, Dept. of Neurology, Haukeland University Hospital, & Dept. of Clinical Medicine, University of Bergen

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Iacob Mathiesen

Role: CONTACT

im@otivio.com

+4746890416

Facility Contacts

Kjell-Morten Myhr, MD/PhD

Role: primary

Kjell-Morten.Myhr@uib.no

Randi C Haugstad, RN

Role: backup

randi.cesilie.haugstad@helse-bergen.no

Other Identifiers

FO-NP001_29032021

Identifier Type: -

Identifier Source: org_study_id