Deuterium Metabolic Imaging in People with Multiple Sclerosis

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 Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
• Intervention / Treatment: Other: No Interventions

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Tobias Gæmelke, PhD-stud; Phone Number: 4528264508; Email: gaemelke@ph.au.dk

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Recruiting
    • Aarhus University
    • Contact: Tobias Gæmelke; Phone Number: 28264508; Email: gaemelke@ph.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MS group; People with relapse remitting multiple sclerosis	Other: No Interventions; No delivered intervention.
HC group; Healthy control participant who are age- and sex-matched to the MS group	Other: No Interventions; No delivered intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lactate to glx ratio	Brain deuterium metabolic imaging determined lactate to glx ratio	2 hours from enrollment to end of assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	Measure of walking capacity as meters walking in six minutes	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	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.	3 hours from enrollment to end of assessment
Handgrip strength	Handgrip dynamometry	3 hours from enrollment to end of assessment
5-sit-to-stand	Time to perform five sit to stand.	3 hours from enrollment to end of assessment
Processing speed - Selective reminding test	Symbol digit modality test, number of symbols translated in 90 s	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	3 hours from enrollment to end of assessment
Glukose level	From blood sample	3 hours from enrollment to end of assessment
Lactat level	From blood sample	3 hours from enrollment to end of assessment
Glucose uptake	Brain deuterium metabolic imaging demined glucose uptake measured by glucose to DHO + glucose ratio	2 hours from enrollment to end of assessment
glucose to glx ratio	Brain deuterium metabolic imaging demined glucose to glx ratio	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	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	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.	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.	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.	7 days from enrollment to end of assessment

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: DMI in MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the European Unions General Data Protection Regulation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No