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

Summary

The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section".

Summary of original trial registration:

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.

Conditions

• Multiple Sclerosis

Interventions

DRUG

Fampridine

sustained-release tablet 10 mg morning and evening.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• The Augustinus Foundation, Denmark.

  collaborator OTHER

• Lounkær Fonden

  collaborator UNKNOWN

• Fonden for scleroseramte på Fyn

  collaborator UNKNOWN

• The Danish Multiple Sclerosis Society

  collaborator UNKNOWN

• TH MAIGAARDS EFTF. FRU LILY BENTHINE LUNDS FOND AF 1. JUNI 1978

  collaborator UNKNOWN

• Fonden til Lægevidenskabens Fremme

  collaborator OTHER

• Overlægeråds forskningsfond

  collaborator UNKNOWN

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Helle H. Nielsen, MD, PhD · Department of Neurology, Odense University Hospital, Odense, Denmark

• Maria Thorning, MSc · Department of Neurology, Odense University Hospital, Odense, Denmark

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-12

Primary Completion

2021-10-15

Completion

2021-10-15

Countries

• Denmark

Study Locations