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

NCT04904016 | Unknown

• 1 other identifier: FO-NP001_29032021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Blood flow; FlowOx™; Stiffness

Outcome Measures

Primary Outcomes (1)

• Self-Reported Spasticity, using Numerical Rating Scale:

  The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher scores mean a worse outcome. To evaluate change in self-reported spasticity using the numerical rating scale (NRS) over the last 24 hours after daily 1-hour self-treatment with FlowOx from baseline to week 4

  4 weeks

Secondary Outcomes (14)

• Desire to continue treatment

  4 weeks

• Self-Reported Spasticity, using Numerical Rating Scale

  3 months, 6 months

• Spasticity - modified Ashworth Scale

  4 weeks, 3 months and 6 months

• Self-reported pain using Numerical Rating Scale

  4 weeks, 3 months and 6 months

• T25-FW

  4 weeks, 3 months, 6 months

Study Arms (1)

Intervention FlowOx treatment

EXPERIMENTAL

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.

Device: FlowOx™

Interventions

FlowOx™ DEVICE

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

Intervention FlowOx treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otivio AS: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

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

Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity; Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kjell-Morten Myhr

  Neuro-SysMed, Haukeland University Hospital, Bergen Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iacob Mathiesen

CONTACT

+4746890416; im@otivio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 27, 2021
• Study Start: May 28, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)