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Deuterium Metabolic Imaging in People with Multiple Sclerosis

Deuterium Metabolic Imaging in People with Multiple Sclerosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06611280
Enrollment
20
Registered
2024-09-24
Start date
2024-10-01
Completion date
2026-05-01
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Brief 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.

Interventions

OTHERNo Interventions

No delivered intervention.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
lactate to glx ratio2 hours from enrollment to end of assessmentBrain deuterium metabolic imaging determined lactate to glx ratio

Secondary

MeasureTime frameDescription
Six-minute walk test3 hours from enrollment to end of assessmentMeasure of walking capacity as meters walking in six minutes
25 meter walk test3 hours from enrollment to end of assessmentMaximal and usual walking speed over 25 feet including a 3 m measurement
Six-spot-step-test3 hours from enrollment to end of assessmentFastes time to kick six block away from six markings on the floor approximatly 1 meter from another in a zig-zag patteren.
Handgrip strength3 hours from enrollment to end of assessmentHandgrip dynamometry
5-sit-to-stand3 hours from enrollment to end of assessmentTime to perform five sit to stand.
Processing speed - Selective reminding test3 hours from enrollment to end of assessmentSymbol digit modality test, number of symbols translated in 90 s
Memory function - Symbol digit modality test3 hours from enrollment to end of assessmentSymbol digit modality test * Short term memory * consistence short term memory * long-term memory
Clinical information on multiple sclerosis - Time since diagnosis7 days from enrollment to end of assessmentInformation on time since diagnosis are exacted from the hospital patient record
Lactat level3 hours from enrollment to end of assessmentFrom blood sample
Glucose uptake2 hours from enrollment to end of assessmentBrain deuterium metabolic imaging demined glucose uptake measured by glucose to DHO + glucose ratio
glucose to glx ratio2 hours from enrollment to end of assessmentBrain deuterium metabolic imaging demined glucose to glx ratio
Clinical information on multiple sclerosis - Disease modifying treatment7 days from enrollment to end of assessmentInformation on current disease modifying treatment are exacted from the hospital patient record
Modified Fatigue Impact Scale7 days from enrollment to end of assessmentA 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.
Clinical information on multiple sclerosis - Expanded disability status score7 days from enrollment to end of assessmentInformation 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.
Multiple Sclerosis Impact Scale7 days from enrollment to end of assessmentA 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.
Glukose level3 hours from enrollment to end of assessmentFrom blood sample

Countries

Denmark

Contacts

Primary ContactTobias Gæmelke, PhD-stud
gaemelke@ph.au.dk4528264508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026