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Recruiting NCT06611280

Deuterium Metabolic Imaging in People with Multiple Sclerosis

Observational Multiple Sclerosis (MS) - Relapsing-remitting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS) - Relapsing-remitting. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this case-control study is to investigate glucose brain metabolism in people with multiple sclerosis and age- and sex-matched healthy controls. The main questions it aims to answer are: * How does brain glucose metabolism in people with multiple sclerosis compare to age- and sex-matched healthy controls? * How is the brain glucose metabolism of people with multiple sclerosis associated with disease severity? Participants will come in for testing lasting approximately three hours and undergo deuterium metabolic imaging, physical function test, cognitive function test, and answer survey.

Interventions

  • Other No Interventions
    No delivered intervention.

Primary outcome measures

  • lactate to glx ratio [Time frame: 2 hours from enrollment to end of assessment]
Secondary outcome measures (12)
  • Six-minute walk test [Time frame: 3 hours from enrollment to end of assessment]
  • 25 meter walk test [Time frame: 3 hours from enrollment to end of assessment]
  • Six-spot-step-test [Time frame: 3 hours from enrollment to end of assessment]
  • Handgrip strength [Time frame: 3 hours from enrollment to end of assessment]
  • 5-sit-to-stand [Time frame: 3 hours from enrollment to end of assessment]
  • Processing speed - Selective reminding test [Time frame: 3 hours from enrollment to end of assessment]
  • Memory function - Symbol digit modality test [Time frame: 3 hours from enrollment to end of assessment]
  • Glukose level [Time frame: 3 hours from enrollment to end of assessment]
  • Lactat level [Time frame: 3 hours from enrollment to end of assessment]
  • Glucose uptake [Time frame: 2 hours from enrollment to end of assessment]
  • glucose to glx ratio [Time frame: 2 hours from enrollment to end of assessment]
  • Clinical information on multiple sclerosis - Disease modifying treatment [Time frame: 7 days from enrollment to end of assessment]

Eligibility criteria

Inclusion criteria

  • Aged 18-60 years.
  • Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria

Exclusion criteria

  • Contraindications for MRI:

Pacemaker, neurostimulator or cholera implant. Metal foreign bodies such as fragments and irremovable piercings. Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).

Claustrophobia. Largest circumference including arms \> 160 cm

  • Pregnancy
  • Competing neurological, psychiatric, or systemic diseases including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed).
  • Participating in other clinical trials with investigational medical products or drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Denmark · 1 center
  • Aarhus University — Aarhus C

Identifiers

NCT: NCT06611280 · DMI in MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗