Multiple SclerosisFlowOx-MSNCT04904016
Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
A study testing FlowOx™ in people with Multiple Sclerosis and Spasticity, Muscle, run by Otivio AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Spasticity, Muscle, Pain
- What is being tested?
- FlowOx™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 28 May 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Neuro-SysMed, Dept. of Neurology, Haukeland University Hospital, & Dept. of Clinical Medicine, University of Bergen
Bergen, 5021
About this study
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
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
- Being tested
- FlowOx™
- Keywords
- Blood flow, FlowOx™, Stiffness
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowOx™Device
The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FlowOx™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (14)
Desire to continue treatment
Proportion of patients who wish to continue treatment with FlowOx beyond 4 weeks
Measured: 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
Measured: 3 months, 6 months
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.
Measured: 4 weeks, 3 months and 6 months
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.
Measured: 4 weeks, 3 months and 6 months
T25-FW
Change of Timed 25-Foot Walk (T25-FW) from baseline
Measured: 4 weeks, 3 months, 6 months
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
Measured: 4 weeks, 3 months, 6 months
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
Measured: 4 weeks, 3 months, 6 months
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
Measured: 4 weeks, 3 months, 6 months
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.
Measured: 4 weeks, 3 months, 6 months
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
Measured: 4 weeks, 3 months, 6 months
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.
Measured: 4 weeks, 3 months, 6 months
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.
Measured: 4 weeks, 3 months and 6 monhts
Compliance
"Compliance" / use of FlowOx, is automatically logged in the machine and will be read after 4 weeks
Measured: 4 weeks, 3 months, 6 months
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
Measured: 4 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start28 May 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otivio AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Kjell-Morten Myhr, Principal investigator, Neuro-SysMed, Haukeland University Hospital, Bergen Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904016
- Sponsor's protocol ID
- FO-NP001_29032021
- Acronym
- FlowOx-MS
- Status last verified
- May 2022
- First submitted
- 4 May 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04904016
- Acronym / sponsor ID
- FlowOx-MS / FO-NP001_29032021
- Conditions
- Multiple Sclerosis, Spasticity, Muscle, Pain
- Keywords
- Blood flow, FlowOx™, Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Otivio ASIndustry (pharma, biotech, devices)
- Collaborators
- Haukeland University Hospital
- Study start
- 28 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention FlowOx treatment | Experimental | Device: FlowOx™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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlowOx™The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot. | Device | Intervention FlowOx treatment |
Primary outcome
Self-Reported Spasticity, using Numerical Rating Scale:
Time frame: 4 weeks
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
14 secondary outcomes
Desire to continue treatment
Time frame: 4 weeks
Self-Reported Spasticity, using Numerical Rating Scale
Time frame: 3 months, 6 months
Spasticity - modified Ashworth Scale
Time frame: 4 weeks, 3 months and 6 months
Self-reported pain using Numerical Rating Scale
Time frame: 4 weeks, 3 months and 6 months
T25-FW
Time frame: 4 weeks, 3 months, 6 months
Expanded Disability Status Scale
Time frame: 4 weeks, 3 months, 6 months
Self-reported sleep (NRS)
Time frame: 4 weeks, 3 months, 6 months
Hospital Anxiety and Depression Scale
Time frame: 4 weeks, 3 months, 6 months
Fatigue Scale for Motor and Cognitive Functions
Time frame: 4 weeks, 3 months, 6 months
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 4 weeks, 3 months, 6 months
SDMT
Time frame: 4 weeks, 3 months, 6 months
Change in medication
Time frame: 4 weeks, 3 months and 6 monhts
Compliance
Time frame: 4 weeks, 3 months, 6 months
Safety- Incidence of device related adverse and serious adverse events
Time frame: 4 weeks, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjell-Morten Myhr principal investigator
Neuro-SysMed, Haukeland University Hospital, Bergen Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowOx™ in people with Multiple Sclerosis and Spasticity, Muscle, run by Otivio AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Spasticity, using Numerical Rating Scale: (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.