Deuterium Metabolic Imaging in People with Multiple Sclerosis

NCT06611280 | Recruiting DMC

• 1 other identifier: DMI in MS
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Outcome Measures

Primary Outcomes (1)

• lactate to glx ratio

  Brain deuterium metabolic imaging determined lactate to glx ratio

  2 hours from enrollment to end of assessment

Secondary Outcomes (16)

• Six-minute walk test

  3 hours from enrollment to end of assessment

• 25 meter walk test

  3 hours from enrollment to end of assessment

• Six-spot-step-test

  3 hours from enrollment to end of assessment

• Handgrip strength

  3 hours from enrollment to end of assessment

• 5-sit-to-stand

  3 hours from enrollment to end of assessment

Study Arms (2)

MS group

People with relapse remitting multiple sclerosis

Other: No Interventions

HC group

Healthy control participant who are age- and sex-matched to the MS group

Other: No Interventions

Interventions

No Interventions OTHER

No delivered intervention.

HC group; MS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Aged 18-60 years.
• Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University

Aarhus C, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Tobias Gæmelke, PhD-stud

CONTACT

4528264508; gaemelke@ph.au.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)