Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06611280

Deuterium Metabolic Imaging in People with Multiple Sclerosis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University

Aarhus C, 8000, Denmark

Location status: Recruiting

Location contact

Tobias Gæmelke

CONTACT

[email protected]

28264508

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No interventions

Other

No delivered intervention.

Primary outcomes

  1. lactate to glx ratio

    Time frame: 2 hours from enrollment to end of assessment

    Brain deuterium metabolic imaging determined lactate to glx ratio

Secondary outcomes

  1. Six-minute walk test

    Time frame: 3 hours from enrollment to end of assessment

    Measure of walking capacity as meters walking in six minutes

  2. 25 meter walk test

    Time frame: 3 hours from enrollment to end of assessment

    Maximal and usual walking speed over 25 feet including a 3 m measurement

  3. Six-spot-step-test

    Time frame: 3 hours from enrollment to end of assessment

    Fastes time to kick six block away from six markings on the floor approximatly 1 meter from another in a zig-zag patteren.

  4. Handgrip strength

    Time frame: 3 hours from enrollment to end of assessment

    Handgrip dynamometry

  5. 5-sit-to-stand

    Time frame: 3 hours from enrollment to end of assessment

    Time to perform five sit to stand.

  6. Processing speed - Selective reminding test

    Time frame: 3 hours from enrollment to end of assessment

    Symbol digit modality test, number of symbols translated in 90 s

  7. Memory function - Symbol digit modality test

    Time frame: 3 hours from enrollment to end of assessment

    Symbol digit modality test

    • Short term memory
    • consistence short term memory
    • long-term memory

  8. Glukose level

    Time frame: 3 hours from enrollment to end of assessment

    From blood sample

  9. Lactat level

    Time frame: 3 hours from enrollment to end of assessment

    From blood sample

  10. Glucose uptake

    Time frame: 2 hours from enrollment to end of assessment

    Brain deuterium metabolic imaging demined glucose uptake measured by glucose to DHO + glucose ratio

  11. glucose to glx ratio

    Time frame: 2 hours from enrollment to end of assessment

    Brain deuterium metabolic imaging demined glucose to glx ratio

  12. Clinical information on multiple sclerosis - Disease modifying treatment

    Time frame: 7 days from enrollment to end of assessment

    Information on current disease modifying treatment are exacted from the hospital patient record

  13. Clinical information on multiple sclerosis - Time since diagnosis

    Time frame: 7 days from enrollment to end of assessment

    Information on time since diagnosis are exacted from the hospital patient record

  14. Modified Fatigue Impact Scale

    Time frame: 7 days from enrollment to end of assessment

    A 29-item questionnaire measuring the impact of multiple sclerosis on the patient. With a minimum score of 29 and a maximum of 116, a higher score indicates a worse outcome.

  15. Clinical information on multiple sclerosis - Expanded disability status score

    Time frame: 7 days from enrollment to end of assessment

    Information on expanded disability status score is exacted from the hospital patient record. The expanded disability status score is a physician rating of disease severity from 0-10 with a higher score indicating higher disability.

  16. Multiple Sclerosis Impact Scale

    Time frame: 7 days from enrollment to end of assessment

    A 21-item questionnaire measuring the impact of multiple sclerosis on the patient. With a minimum score of 0 and a maximum of 84, a higher score indicates a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Tobias Gæmelke, PhD-stud

CONTACT

[email protected]

4528264508

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.