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Trial record 37 of 80602 for:    measured

Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking Technique (MUST)

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ClinicalTrials.gov Identifier: NCT03847545
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
Odense University Hospital
Sygehus Lillebaelt
University of Miami
Region of Southern Denmark
The Augustinus Foundation, Denmark.
The Lounkaer Foundation
Fonden for scleroseramte paa Fyn
The Danish Multiple Sclerosis Society
The Lily Benthine Lunds Foundation
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:

Despite effective treatments, the majority of patients with multiple sclerosis experience walking impairments to a degree where walking aids or a wheelchair is required. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective in approximately 40% of the patients. At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. The treatment is offered on the basis of a measurable improved walking distance.

This is shown today using simple performance-based walking tests that are difficult to complete for those MS patients who are without gait function but could still benefit from fampridine treatment.

Ultrasound speckle tracking is a non-invasive ultrasound technique, with the potential to measure muscle function, including muscle contractility (through strain). Ultrasound speckle tracking is designed for dynamic cardiac muscular examination, but can in a modified version be used for assessment of the skeletal muscles.

The purpose of this project is to use ultrasound speckle tracking to monitor muscle contractility in MS patients receiving vs. not receiving fampridine treatment. Furthermore, to relate these results to biomarkers in blood and urine to examine disease progression and muscle activity.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Fampridine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective cohort Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The participants who have an effect of 20% or more after 14 days of Fampridine treatment, measured using 6 Spot Step Test (SSST) or Timed 25 Footwalk (F25-FW), will continue as cases and will receive Fampridine throughout the trial.
Drug: Fampridine
sustained-release tablet 10 mg morning and evening.

No Intervention: Non-treated controls
Participants who do not have an effect of 20% or more after 14 days of Fampridine treatment, measured using 6 Spot Step Test (SSST) or Timed 25 Footwalk (F25-FW), will continue as untreated controls. They will not receive Fampridine in the remainder of the trial.



Primary Outcome Measures :
  1. Muscle strain of the soleus muscle [ Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up) ]
    Change in muscle strain (percentage of deformation during a contractile cycle of the muscle) before and during fampridine treatment. The muscle strain will be measured during submaximal isometric contractions of 20% 40% and 60%.


Secondary Outcome Measures :
  1. Muscle strain of the supraspinatus muscle [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in muscle strain (percentage of deformation during a contractile cycle of the muscle) before and during fampridine treatment. The muscle strain will be measured during submaximal isometric contractions of 40%, 60% and 80%.

  2. Muscle strain of the biceps brachii muscle [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in muscle strain (percentage of deformation during a contractile cycle of the muscle) before and during fampridine treatment. The muscle strain will be measured during submaximal isometric contractions of 20% 40% and 60%.

  3. Muscle strain of the soleus muscle [ Time Frame: 14 days, 52 weeks (Change from: 14 days follow-up to 52 weeks) ]
    Change in muscle strain (percentage of deformation during a contractile cycle of the muscle) before and during fampridine treatment. The muscle strain will be measured during submaximal isometric contractions of 20% 40% and 60%.


Other Outcome Measures:
  1. Neurological examination - Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in EDSS. The scale ranges from 0 to 10, where 0 indicates that the patient is unaffected by the disease, while 10 indicates death by MS.

  2. Neurological examination - Multiple Sclerosis Impairment Scale (MSIS) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in MSIS. Normal examination corresponds to the value 0 and the theoretical maximum score is 204.

  3. Functional test - 6 Spot Step Test (SSST) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in time it takes the participant to walk through a rectangular area of 1x 5 meters while 5 cylinder blocks must be kicked out of 5 circles marked on the floor.

  4. Functional test - Timed 25 Footwalk (T25-FW) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in time it takes the participant to walk as safe and as quickly as possible through a straight clearly marked lane of 7.62 meters (25 feet).

  5. Functional test - 2-minute Walk Test (2MWT) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in distance that the participant is able to walk in 2 minutes.

  6. Functional test - Nine Hole Peg Test (9HPT) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in time it takes the participant to collect 9 sticks individually by hand and put them in 9 holes and then to remove them again. The test is performed with each hand.

  7. Peak range of motion (kinematic) - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in peak range of motion (degrees) for ankle, knee and hip in sagittal, frontal and transverse plane. Measures are captured during a 3D Vicon gait analysis.

  8. Peak and mean joint moments (kinetic) - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in peak and mean joint moments (Nm · BW-1) for ankle, knee and hip in sagittal, frontal and transverse plane. Measures are captured during a 3D Vicon gait analysis. relevant kinetic measures using a 3D Vicon motion capture analysis.

  9. Gait Deviation Index (GDI) - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in GDI. GDI is a unitless value from 0 to 100. It is based upon kinematic data and is an overall quantitative index that summarises the overall gait pathology into a single score for each patient by comparison with non-pathological gait. A GDI value of 100 represents the absence of gait pathology, and each 10-point decrement below 100 indicates one standard deviation from normal gait kinematics

  10. Walking speed - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in walking speed (m/s)

  11. Cadence - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in cadence (steps/min.)

  12. Stride length - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in stride length (m)

  13. Step length - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in step length (m)

  14. Step width - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in step width (m)

  15. Single support - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in single support (percentage of stride)

  16. Single Limp Index - (subgroup of 30 allocated to 3D gait analysis) [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change Limp Index (left vs. right in %)

  17. Questionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in MSWS-12. Data is converted to a scale from 0 to 100, where 0 represents the best and 100 the worst. A change score of at least -4 represents a clinically meaningful improvement in the gait function.

  18. Questionnaire - Oxford Shoulder Score (OSS), Danish version [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in OSS. Symptoms are rated between 1 (minimal symptoms) and 5 (severe symptoms). The total score of the 12 questions combined is minimum 12 and maximum 60.

  19. Questionnaire - UCLA Activity Scale, Danish version [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in the University of California Los Angeles activity-level rating (UCLA activity scale), Danish version. On a 10-point scale, the option is marked that matches the level of intensity and frequency of physical activity best, where 1 ="Wholly inactive: depend on others, cannot leave residence, and 10 =" Regularly participates in impact sports".

  20. Neurofilament [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in neurofilament - biomarker for neurodegeneration. Simoa ELISA in serum/plasma pg/ml

  21. TNF [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in TNF - biomarker for inflammation, ELISA in plasma/serum pg/ml

  22. TNFR1 [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in TNFR1 - biomarker for inflammation, ELISA in plasma/serum pg/ml

  23. TNFR2 [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in TNFR2 - biomarker for inflammation, ELISA in plasma/serum pg/ml

  24. IL-1alpha [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in IL-1alpha, biomarker for inflammation, ELISA in plasma/serum pg/ml

  25. IL-1beta [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in IL-1beta - biomarker for inflammation, ELISA in plasma/serum pg/ml

  26. IL-1Ra [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in IL-1Ra - biomarker for inflammation, ELISA in plasma/serum pg/ml

  27. Creatinin phosphokinase [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in Creatinin phosphokinase - biomarker for muscle function, Enzymassay in plasma/serum micromol/L

  28. Lactate dehydrogenase [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in Lactate dehydrogenase - biomarker for muscle function, Enzymassay Plasma U/liter

  29. Myoglobin [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in myoglobin - biomarker for muscle function, ELISA in urine and plasma microg/L

  30. Skeletal troponin [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in Skeletal troponin - biomarker for muscle function, ELISA in serum/plasma microg/L

  31. eGFR [ Time Frame: Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") ]
    Change in eGFR - biomarker for kidney function, serum/plasma ml/min.

  32. Test for urinary tract infection (UTI) [ Time Frame: Baseline, 14 days follow-up, 52 weeks follow-up ]
    Testing for UTI - marker for infection, using strips



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fills the criteria for fampridine treatment
  • Fills the diagnostic McDonald criteria for MS
  • Age between 18 and 100 years
  • EDSS between 4 and 7

Exclusion Criteria:

  • Diagnosed epilepsy
  • MS attack or an acute decrease of functional capacity within the last 60 days
  • Change in immunomodulatory treatment within the last 60 days
  • Cancer within the last 5 years
  • Clinically significant systemic disease
  • Concurrent treatment with cimetidine, carvediol, propanolol and metformine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847545


Contacts
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Contact: Maria Thorning, MSc +45 26230578 maria.thorning.christensen@rsyd.dk
Contact: Helle H. Nielsen, MD, PhD +45 60116758 helle.hvilsted.nielsen@rsyd.dk

Locations
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Denmark
University of Southern Denmark - Odense Univarsity Hospital Recruiting
Odense C, Denmark, 5000
Contact: Maria Thorning, MSc    26230578    maria.thorning.christensen@rsyd.dk   
Contact: Helle H Nielsen, MD, PhD    60116758    helle.hvilsted.nielsen@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Sygehus Lillebaelt
University of Miami
Region of Southern Denmark
The Augustinus Foundation, Denmark.
The Lounkaer Foundation
Fonden for scleroseramte paa Fyn
The Danish Multiple Sclerosis Society
The Lily Benthine Lunds Foundation
Investigators
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Study Director: Helle H. Nielsen, MD, PhD Department of Molecular medicine, University of Southern Denmark; Department of Neurology, Odense University Hospital
Principal Investigator: Maria Thorning, MSc Department of Molecular medicine, University of Southern Denmark; Department of Neurology, Odense University Hospital

Publications:
Frich, L.H., et al., Direct isometric muscle strain analyses using speckle tracking technology. A validation study, in European Muscle Conference 2017. 2017, Journal of Muscle Research and Cell Motility: Potsdam

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03847545     History of Changes
Other Study ID Numbers: mariathorning
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
Speckle tracking ultrasonography
Muscle strain
Fampridine
Multiple Sclerosis
Neurological diseases
Biomarkers
muscle contractility
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action