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New treatment option for Sclerosis
Official title Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
ClinicalTrials.gov ID: NCT06201026
What this study is testing
- What it's testing
- Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
- MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose...
- With a high level of fatigue, corresponding to an FSS score \> 4
- Expanded Disability Status Scale (EDSS) score \< 4
- Medical Research Council (MRC) testing ≥ 4 in all leg muscles
You likely can't join if
- Spasticity or severe cerebellar ataxia in either leg.
- Abnormal range of movement of the toes and/or ankle
- Musculoskeletal injury that impairs pedalling
- Appearance of a multiple sclerosis attack in the 90 days preceding the study
- Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking...
- History of comorbid illness or conditions that would compromise the subject's safety during the study
See the full eligibility criteria
- Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
- MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old
- With a high level of fatigue, corresponding to an FSS score \> 4
- Expanded Disability Status Scale (EDSS) score \< 4
- Medical Research Council (MRC) testing ≥ 4 in all leg muscles
- Ability to walk for 10 minutes without stopping (self-reported)
- Have a mobile phone with internet access
- Affiliated with or benefiting from a social security scheme
- Have freely given their written consent after being informed of the aim, the procedure and the potential risks involved
- Spasticity or severe cerebellar ataxia in either leg.
- Abnormal range of movement of the toes and/or ankle
- Musculoskeletal injury that impairs pedalling
- Appearance of a multiple sclerosis attack in the 90 days preceding the study
- Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...)
- History of comorbid illness or conditions that would compromise the subject's safety during the study
- Participation at the same time in another medical intervention study or having participated in such a study in the 30 days prior to this study
- Pregnant and breast-feeding women
- Patients who are unable to understand the purpose of the study and the conditions under which it will be conducted, or who are unable to give their consent.
- Patients deprived of their liberty or under guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Etienne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Etienne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.