Clinical trial NCT06611280: Deuterium Metabolic Imaging in People with Multiple Sclerosis
Official title: Deuterium Metabolic Imaging in People with Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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 \&gt; 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.

Primary outcomes:
measure: lactate to glx ratio
timeFrame: 2 hours from enrollment to end of assessment
Secondary outcomes:
measure: Six-minute walk test
timeFrame: 3 hours from enrollment to end of assessment
measure: 25 meter walk test
timeFrame: 3 hours from enrollment to end of assessment
measure: Six-spot-step-test
timeFrame: 3 hours from enrollment to end of assessment
measure: Handgrip strength
timeFrame: 3 hours from enrollment to end of assessment
measure: 5-sit-to-stand
timeFrame: 3 hours from enrollment to end of assessment
measure: Processing speed - Selective reminding test
timeFrame: 3 hours from enrollment to end of assessment
measure: Memory function - Symbol digit modality test
timeFrame: 3 hours from enrollment to end of assessment
measure: Glukose level
timeFrame: 3 hours from enrollment to end of assessment
measure: Lactat level
timeFrame: 3 hours from enrollment to end of assessment
measure: Glucose uptake
timeFrame: 2 hours from enrollment to end of assessment
measure: glucose to glx ratio
timeFrame: 2 hours from enrollment to end of assessment
measure: Clinical information on multiple sclerosis - Disease modifying treatment
timeFrame: 7 days from enrollment to end of assessment
measure: Clinical information on multiple sclerosis - Time since diagnosis
timeFrame: 7 days from enrollment to end of assessment
measure: Modified Fatigue Impact Scale
timeFrame: 7 days from enrollment to end of assessment
measure: Clinical information on multiple sclerosis - Expanded disability status score
timeFrame: 7 days from enrollment to end of assessment
measure: Multiple Sclerosis Impact Scale
timeFrame: 7 days from enrollment to end of assessment
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University
Study officials:
References: