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RecruitingNCT06611280Updated Oct 9, 2024

Deuterium Metabolic Imaging in People with Multiple Sclerosis

An observational study in Multiple Sclerosis (MS) - Relapsing-remitting, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by University of Aarhus · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis (MS) - Relapsing-remitting
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study seeks to include people with relapsing remitting multiple sclerosis that are otherwise healthy and age- and sex-matched healthy control participants.

Inclusion criteria

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

Exclusion 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • MS group

    People with relapse remitting multiple sclerosis

    Other: No Interventions

  • HC group

    Healthy control participant who are age- and sex-matched to the MS group

    Other: No Interventions

Interventions

  • OtherNo Interventions

    No delivered intervention.

06

What researchers measure

Primary outcomes

  1. lactate to glx ratio

    Brain deuterium metabolic imaging determined lactate to glx ratio

    Time frame: 2 hours from enrollment to end of assessment

Secondary outcomes

  1. Six-minute walk test

    Measure of walking capacity as meters walking in six minutes

    Time frame: 3 hours from enrollment to end of assessment

  2. 25 meter walk test

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

    Time frame: 3 hours from enrollment to end of assessment

  3. Six-spot-step-test

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

    Time frame: 3 hours from enrollment to end of assessment

  4. Handgrip strength

    Handgrip dynamometry

    Time frame: 3 hours from enrollment to end of assessment

  5. 5-sit-to-stand

    Time to perform five sit to stand.

    Time frame: 3 hours from enrollment to end of assessment

  6. Processing speed - Selective reminding test

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

    Time frame: 3 hours from enrollment to end of assessment

  7. Memory function - Symbol digit modality test

    Symbol digit modality test * Short term memory * consistence short term memory * long-term memory

    Time frame: 3 hours from enrollment to end of assessment

  8. Glukose level

    From blood sample

    Time frame: 3 hours from enrollment to end of assessment

  9. Lactat level

    From blood sample

    Time frame: 3 hours from enrollment to end of assessment

  10. Glucose uptake

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

    Time frame: 2 hours from enrollment to end of assessment

  11. glucose to glx ratio

    Brain deuterium metabolic imaging demined glucose to glx ratio

    Time frame: 2 hours from enrollment to end of assessment

  12. Clinical information on multiple sclerosis - Disease modifying treatment

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

    Time frame: 7 days from enrollment to end of assessment

  13. Clinical information on multiple sclerosis - Time since diagnosis

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

    Time frame: 7 days from enrollment to end of assessment

  14. Modified Fatigue Impact Scale

    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.

    Time frame: 7 days from enrollment to end of assessment

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

    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.

    Time frame: 7 days from enrollment to end of assessment

  16. Multiple Sclerosis Impact Scale

    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.

    Time frame: 7 days from enrollment to end of assessment

07

Study locations

1 of 1 sites recruiting
  • Aarhus University
    Aarhus C, 8000, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Due to the European Unions General Data Protection Regulation.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06611280
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Sep 24, 2024
Start date
Oct 1, 2024
Primary completion
Oct 1, 2025 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Oct 9, 2024

Study contacts

Tobias Gæmelke, PhD-stud
Contact
gaemelke@ph.au.dk
4528264508

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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