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Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain

NCT05562453 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-06-29

No results posted yet for this study

Summary

The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.

Conditions

Interventions

DEVICE

FlowOx 2.0

Subjects randomized to tretament with the investigational device will receive treatment with -40 mmHg intermittent negative pressure for 60 minutes per day.

DEVICE

FlowOx2.0 (Sham)

Subjects randomized to treatment with the comparator will receive treatment with -10 mmHg intermittent negative pressure for 60 minutes per day.

Sponsors & Collaborators

  • Otivio AS

    lead INDUSTRY

Principal Investigators

  • Kjell-Morten Myhr, MD, PhD · Dept. of Neurology Haukeland Univ. Hospital & Dept. of Clin. Med., Univ. of Bergen, Bergen, Norway

  • Sara Haghighi Mobarhan Smith, MD, PhD · Department of Neurology, Motala Hospital, Motala, Sweden

  • Peter Vestergaard Rasmussen, MD, PhD · Department of Clinical Medicine - The Department of Neurology, Aarhus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2023-07-15
Completion
2023-08-15

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562453 on ClinicalTrials.gov