Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting; Fatigue

• Registration Number: NCT06569550
• Lead Sponsor: Danish Research Centre for Magnetic Resonance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - A confirmed diagnosis of relapse-remitting multiple sclerosis, according to most<br> recent McDonald's criteria (Thompson et al., 2018). This diagnosis must not be more<br> recent than 3 months<br><br> - Must have fatigue as a complaint, and an FSMC score corresponding to at least<br> moderate fatigue (>53)<br><br> - Stable MS medication for at least 3 months<br><br>Exclusion Criteria:<br><br> - Pregnancy, any subject with the potential to become pregnant must ensure against<br> this (e.g. by taking oral contraceptives, or other high efficacy method)<br><br> - MS Relapse or steroid treatment within 3 months prior to inclusion<br><br> - Current treatment targeted towards fatigue, or previous if discontinued within 3<br> months prior to inclusion<br><br> - History of neurologic disease or other significant medical conditions, aside from MS<br><br> - EDSS > 6.5<br><br> - Major psychiatric disorder, including current clinical depression<br><br> - Pacemaker or other implanted electronic devices<br><br> - Any intracranial metal<br><br> - Any metallic implant incompatible with MR scanning<br><br> - Claustrophobia<br><br> - Either patient or their close relatives suffering from epilepsy<br><br> - Current Drug or alcohol abuse

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in patient reported fatigue severity, measured by the Fatigue Scale for Motor and Cognitive Symptoms (FSMC) from baseline to +6 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in regional brain tissue concentration of glutamate/glutamine in the stimulated premotor cortex, measured by single-voxel Magnetic Resonance Spectroscopy;Change from baseline in Brain tissue concentration of GABA in the stimulated premotor cortex, measured by single-voxel Magnetic Resonance Spectroscopy;Change from baseline in patient reported fatigue severity, measured by the Fatigue Scale for Motor and Cognitive Symptoms (FSMC);Change from baseline in objective fatiguability, measured by the Fatiguability Index (FI);Change from baseline in patient-reported fatiguability, measured by the Pittsburgh Fatiguability Score (PFS)