Multiple Sclerosis (MS) - Relapsing-remittingNCT06611280
Deuterium Metabolic Imaging in People with Multiple Sclerosis
An observational study of Multiple Sclerosis (MS) - Relapsing-remitting, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Aged 18-60 years.
- Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University
Aarhus C, 8000
Tobias Gæmelke, 28264508, gaemelke@ph.au.dk
About this study
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.
- Being tested
- No Interventions
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No delivered intervention.
| Study group | Role | What they receive |
|---|---|---|
| MS group | People with relapse remitting multiple sclerosis Receives: Other: No Interventions | |
| HC group | Healthy control participant who are age- and sex-matched to the MS group Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate to glx ratio
Brain deuterium metabolic imaging determined lactate to glx ratio
Measured: 2 hours from enrollment to end of assessment
Secondary outcomes (16)
Six-minute walk test
Measure of walking capacity as meters walking in six minutes
Measured: 3 hours from enrollment to end of assessment
25 meter walk test
Maximal and usual walking speed over 25 feet including a 3 m measurement
Measured: 3 hours from enrollment to end of assessment
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.
Measured: 3 hours from enrollment to end of assessment
Handgrip strength
Handgrip dynamometry
Measured: 3 hours from enrollment to end of assessment
5-sit-to-stand
Time to perform five sit to stand.
Measured: 3 hours from enrollment to end of assessment
Processing speed - Selective reminding test
Symbol digit modality test, number of symbols translated in 90 s
Measured: 3 hours from enrollment to end of assessment
Memory function - Symbol digit modality test
Symbol digit modality test
- Short term memory
- consistence short term memory
- long-term memory
Measured: 3 hours from enrollment to end of assessment
Glukose level
From blood sample
Measured: 3 hours from enrollment to end of assessment
Lactat level
From blood sample
Measured: 3 hours from enrollment to end of assessment
Glucose uptake
Brain deuterium metabolic imaging demined glucose uptake measured by glucose to DHO + glucose ratio
Measured: 2 hours from enrollment to end of assessment
glucose to glx ratio
Brain deuterium metabolic imaging demined glucose to glx ratio
Measured: 2 hours from enrollment to end of assessment
Clinical information on multiple sclerosis - Disease modifying treatment
Information on current disease modifying treatment are exacted from the hospital patient record
Measured: 7 days from enrollment to end of assessment
Clinical information on multiple sclerosis - Time since diagnosis
Information on time since diagnosis are exacted from the hospital patient record
Measured: 7 days from enrollment to end of assessment
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.
Measured: 7 days from enrollment to end of assessment
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.
Measured: 7 days from enrollment to end of assessment
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.
Measured: 7 days from enrollment to end of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611280
- Sponsor's protocol ID
- DMI in MS
- Status last verified
- Aug 2024
- First submitted
- 3 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the European Unions General Data Protection Regulation.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deuterium Metabolic Imaging in People with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06611280
- Acronym / sponsor ID
- DMI in MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS group | – | Other: No InterventionsPeople with relapse remitting multiple sclerosis |
| HC group | – | Other: No InterventionsHealthy control participant who are age- and sex-matched to the MS group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Aged 18-60 years.
- Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo delivered intervention. | Other | HC group, MS group |
Primary outcome
lactate to glx ratio
Time frame: 2 hours from enrollment to end of assessment
Brain deuterium metabolic imaging determined lactate to glx ratio
16 secondary outcomes
Six-minute walk test
Time frame: 3 hours from enrollment to end of assessment
25 meter walk test
Time frame: 3 hours from enrollment to end of assessment
Six-spot-step-test
Time frame: 3 hours from enrollment to end of assessment
Handgrip strength
Time frame: 3 hours from enrollment to end of assessment
5-sit-to-stand
Time frame: 3 hours from enrollment to end of assessment
Processing speed - Selective reminding test
Time frame: 3 hours from enrollment to end of assessment
Memory function - Symbol digit modality test
Time frame: 3 hours from enrollment to end of assessment
Glukose level
Time frame: 3 hours from enrollment to end of assessment
Lactat level
Time frame: 3 hours from enrollment to end of assessment
Glucose uptake
Time frame: 2 hours from enrollment to end of assessment
glucose to glx ratio
Time frame: 2 hours from enrollment to end of assessment
Clinical information on multiple sclerosis - Disease modifying treatment
Time frame: 7 days from enrollment to end of assessment
Clinical information on multiple sclerosis - Time since diagnosis
Time frame: 7 days from enrollment to end of assessment
Modified Fatigue Impact Scale
Time frame: 7 days from enrollment to end of assessment
Clinical information on multiple sclerosis - Expanded disability status score
Time frame: 7 days from enrollment to end of assessment
Multiple Sclerosis Impact Scale
Time frame: 7 days from enrollment to end of assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No. Due to the European Unions General Data Protection Regulation.
Related trials for Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS) - Relapsing-remitting, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Gæmelke, PhD-stud (4528264508, gaemelke@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lactate to glx ratio (time frame: 2 hours from enrollment to end of assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.