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

Primary Purpose

Multiple Sclerosis, Spasticity, Muscle, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
FlowOx™
Sponsored by
Otivio AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Blood flow, FlowOx™, Stiffness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention FlowOx treatment

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Desire to continue treatment
Proportion of patients who wish to continue treatment with FlowOx beyond 4 weeks
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 compared to baseline
Spasticity - modified Ashworth Scale
The unabbreviated scale title: Modified Ashworth Scale The minimum and maximum values: 0, 4 Higher scores mean a worse outcome. Change in spasticity measured by modified Ashworth scale from baseline to week 4, month 3 and month 6.
Self-reported pain using Numerical Rating Scale
The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher score means worse pain. 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.
T25-FW
Change of Timed 25-Foot Walk (T25-FW) from baseline
Expanded Disability Status Scale
The unabbreviated scale title: Expanded Disability Status Scale The minimum and maximum values: 0, 10 Higher score means worse disability status. Change of functional score measured by Expanded Disability Status Scale (EDSS) and compared to baseline
Self-reported sleep (NRS)
The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher score means worse sleep. Change in self reported sleep quality will measured by (NRS) and compared to baseline
Hospital Anxiety and Depression Scale
The unabbreviated scale title: Hospital Anxiety and Depression Scale The minimum and maximum values: 0, 3 Higher score means worse outcome. The Scale has 14 questions, the scores will be summarized at each time point and compared to baseline
Fatigue Scale for Motor and Cognitive Functions
The unabbreviated scale title: Fatigue Scale for Motor and Cognitive Functions (FSMC) The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19. Changes in the scores will be compared to baseline.
Multiple Sclerosis Impact Scale (MSIS-29)
The unabbreviated scale title: Multiple Sclerosis Impact Scale The minimum and maximum values: 1, 5 Higher score means worse condition. There are 29 questions, change in reported status will be compared to baseline
SDMT
Change in cognition measured by the Symbol Digit Modalities Test (SDMT) The Symbol Digit Modalities Test (SDMT) is a cognitive task. It consists of a sheet of paper with, at the top, a sequence of nine symbols and nine corresponding numbers (key). The task sequence consists of a series of symbols, each with a blank space underneath. Within a 90-second time limit the subject is required, consulting the key as necessary, to insert the numbers associated with the symbols. Changes in the performance will be compared to baseline.
Change in medication
Medication used by the patients at the start of the trial will be recorded. Any change in frequency of use or dose of the medication to treat spasticity an/or pain will be recorded and compared to baseline.
Compliance
"Compliance" / use of FlowOx, is automatically logged in the machine and will be read after 4 weeks
Safety- Incidence of device related adverse and serious adverse events
The number and type of adverse events and servere device related events during the study will be recorded. To evaluate safety of FlowOx by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality

Full Information

First Posted
May 4, 2021
Last Updated
May 21, 2021
Sponsor
Otivio AS
Collaborators
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04904016
Brief Title
Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
Acronym
FlowOx-MS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otivio AS
Collaborators
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Spasticity, Muscle, Pain
Keywords
Blood flow, FlowOx™, Stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention FlowOx treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
FlowOx™
Intervention Description
The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot.
Primary Outcome Measure Information:
Title
Self-Reported Spasticity, using Numerical Rating Scale:
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Desire to continue treatment
Description
Proportion of patients who wish to continue treatment with FlowOx beyond 4 weeks
Time Frame
4 weeks
Title
Self-Reported Spasticity, using Numerical Rating Scale
Description
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 compared to baseline
Time Frame
3 months, 6 months
Title
Spasticity - modified Ashworth Scale
Description
The unabbreviated scale title: Modified Ashworth Scale The minimum and maximum values: 0, 4 Higher scores mean a worse outcome. Change in spasticity measured by modified Ashworth scale from baseline to week 4, month 3 and month 6.
Time Frame
4 weeks, 3 months and 6 months
Title
Self-reported pain using Numerical Rating Scale
Description
The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher score means worse pain. 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.
Time Frame
4 weeks, 3 months and 6 months
Title
T25-FW
Description
Change of Timed 25-Foot Walk (T25-FW) from baseline
Time Frame
4 weeks, 3 months, 6 months
Title
Expanded Disability Status Scale
Description
The unabbreviated scale title: Expanded Disability Status Scale The minimum and maximum values: 0, 10 Higher score means worse disability status. Change of functional score measured by Expanded Disability Status Scale (EDSS) and compared to baseline
Time Frame
4 weeks, 3 months, 6 months
Title
Self-reported sleep (NRS)
Description
The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher score means worse sleep. Change in self reported sleep quality will measured by (NRS) and compared to baseline
Time Frame
4 weeks, 3 months, 6 months
Title
Hospital Anxiety and Depression Scale
Description
The unabbreviated scale title: Hospital Anxiety and Depression Scale The minimum and maximum values: 0, 3 Higher score means worse outcome. The Scale has 14 questions, the scores will be summarized at each time point and compared to baseline
Time Frame
4 weeks, 3 months, 6 months
Title
Fatigue Scale for Motor and Cognitive Functions
Description
The unabbreviated scale title: Fatigue Scale for Motor and Cognitive Functions (FSMC) The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19. Changes in the scores will be compared to baseline.
Time Frame
4 weeks, 3 months, 6 months
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
The unabbreviated scale title: Multiple Sclerosis Impact Scale The minimum and maximum values: 1, 5 Higher score means worse condition. There are 29 questions, change in reported status will be compared to baseline
Time Frame
4 weeks, 3 months, 6 months
Title
SDMT
Description
Change in cognition measured by the Symbol Digit Modalities Test (SDMT) The Symbol Digit Modalities Test (SDMT) is a cognitive task. It consists of a sheet of paper with, at the top, a sequence of nine symbols and nine corresponding numbers (key). The task sequence consists of a series of symbols, each with a blank space underneath. Within a 90-second time limit the subject is required, consulting the key as necessary, to insert the numbers associated with the symbols. Changes in the performance will be compared to baseline.
Time Frame
4 weeks, 3 months, 6 months
Title
Change in medication
Description
Medication used by the patients at the start of the trial will be recorded. Any change in frequency of use or dose of the medication to treat spasticity an/or pain will be recorded and compared to baseline.
Time Frame
4 weeks, 3 months and 6 monhts
Title
Compliance
Description
"Compliance" / use of FlowOx, is automatically logged in the machine and will be read after 4 weeks
Time Frame
4 weeks, 3 months, 6 months
Title
Safety- Incidence of device related adverse and serious adverse events
Description
The number and type of adverse events and servere device related events during the study will be recorded. To evaluate safety of FlowOx by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality
Time Frame
4 weeks, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iacob Mathiesen
Phone
+4746890416
Email
im@otivio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell-Morten Myhr
Organizational Affiliation
Neuro-SysMed, Haukeland University Hospital, Bergen Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro-SysMed, Dept. of Neurology, Haukeland University Hospital, & Dept. of Clinical Medicine, University of Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kjell-Morten Myhr, MD/PhD
Email
Kjell-Morten.Myhr@uib.no
First Name & Middle Initial & Last Name & Degree
Randi C Haugstad, RN
Email
randi.cesilie.haugstad@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Hilde Norborg, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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