Status:
RECRUITING
Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
Lead Sponsor:
Danish Research Centre for Magnetic Resonance
Collaborating Sponsors:
Danish Multiple Sclerosis Center
Scleroseforeningen
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Fatigue
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS) of the left premotor cortex can lessen fatigue in patients with Multiple Sclerosis, and if this is a ...
Detailed Description
BACKGROUND: Multiple sclerosis (MS) is an immune mediated disease, targeting the central nervous system. Globally, the prevalence and incidence are increasing. It is a chronic condition, with no know...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of relapse-remitting multiple sclerosis, according to most recent McDonald's criteria (Thompson et al., 2018). This diagnosis must not be more recent than 3 months
- Must have fatigue as a complaint, and an FSMC score corresponding to at least moderate fatigue (\>53)
- Stable MS medication for at least 3 months
Exclusion
- Pregnancy, any subject with the potential to become pregnant must ensure against this (e.g. by taking oral contraceptives, or other high efficacy method)
- MS Relapse or steroid treatment within 3 months prior to inclusion
- Current treatment targeted towards fatigue, or previous if discontinued within 3 months prior to inclusion
- History of neurologic disease or other significant medical conditions, aside from MS
- EDSS \> 6.5
- Major psychiatric disorder, including current clinical depression
- Pacemaker or other implanted electronic devices
- Any intracranial metal
- Any metallic implant incompatible with MR scanning
- Claustrophobia
- Either patient or their close relatives suffering from epilepsy
- Current Drug or alcohol abuse
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06569550
Start Date
August 14 2024
End Date
February 1 2026
Last Update
January 23 2025
Active Locations (1)
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1
Danish Research Centre for Magnetic Resonance
Hvidovre, Capital Region, Denmark, 2650