Deuterium Metabolic Imaging in People with Multiple Sclerosis
- Conditions
- Multiple Sclerosis (MS) - Relapsing-remitting
- Interventions
- Other: No Interventions
- Registration Number
- NCT06611280
- Lead Sponsor
- University of Aarhus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Aged 18-60 years.
- Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MS group No Interventions People with relapse remitting multiple sclerosis HC group No Interventions Healthy control participant who are age- and sex-matched to the MS group
- Primary Outcome Measures
Name Time Method lactate to glx ratio 2 hours from enrollment to end of assessment Brain deuterium metabolic imaging determined lactate to glx ratio
- Secondary Outcome Measures
Name Time Method Six-minute walk test 3 hours from enrollment to end of assessment Measure of walking capacity as meters walking in six minutes
25 meter walk test 3 hours from enrollment to end of assessment Maximal and usual walking speed over 25 feet including a 3 m measurement
Six-spot-step-test 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.
Handgrip strength 3 hours from enrollment to end of assessment Handgrip dynamometry
5-sit-to-stand 3 hours from enrollment to end of assessment Time to perform five sit to stand.
Processing speed - Selective reminding test 3 hours from enrollment to end of assessment Symbol digit modality test, number of symbols translated in 90 s
Memory function - Symbol digit modality test 3 hours from enrollment to end of assessment Symbol digit modality test
* Short term memory
* consistence short term memory
* long-term memoryGlukose level 3 hours from enrollment to end of assessment From blood sample
Lactat level 3 hours from enrollment to end of assessment From blood sample
Glucose uptake 2 hours from enrollment to end of assessment Brain deuterium metabolic imaging demined glucose uptake measured by glucose to DHO + glucose ratio
glucose to glx ratio 2 hours from enrollment to end of assessment Brain deuterium metabolic imaging demined glucose to glx ratio
Clinical information on multiple sclerosis - Disease modifying treatment 7 days from enrollment to end of assessment Information on current disease modifying treatment are exacted from the hospital patient record
Clinical information on multiple sclerosis - Time since diagnosis 7 days from enrollment to end of assessment Information on time since diagnosis are exacted from the hospital patient record
Modified Fatigue Impact Scale 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.
Clinical information on multiple sclerosis - Expanded disability status score 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.
Multiple Sclerosis Impact Scale 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.
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus C, Denmark