Status:
COMPLETED
Exercise Therapy in Multiple Sclerosis
Lead Sponsor:
IRCCS San Raffaele Roma
Collaborating Sponsors:
Neuromed IRCCS
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Exercise or active rehabilitation is a non-pharmacological approach increasingly used for people with Multiple Sclerosis (MS), in support of disease-modifying therapies (DMTs), with the aim of improvi...
Detailed Description
Clinical manifestations of Multiple Sclerosis (MS) indicate the involvement of motor, sensory, visual systems, cognition and emotion, as well as peripheral autonomic system (PAS). Disease modifying th...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent to the study;
- Diagnosis of MS definite according to 2010 revised McDonald's criteria (Polman et al., 2011);
- Age range 18-65 (included);
- EDSS range between 4,5 and 6,5 (included);
- Ability to participate to the study protocol.
Exclusion
- Inability to provide written informed consent to the study;
- Altered blood count;
- Female with a positive pregnancy test at baseline or having active pregnancy plans in the following months after the beginning of the protocol;
- Contraindications to gadolinium (MRI);
- Contraindications to TMS;
- Patients with comorbidities for a neurological disease other than MS, included other neurodegenerative chronic diseases or chronic infections (i.e tuberculosis, infectious hepatitis, HIV/AIDS);
- Unstable medical condition or infections;
- Use of medications with increased risk of seizures (i.e. Fampridine, 4- Aminopyridine);
- Concomitant use of drugs that may alter synaptic transmission and plasticity (cannabinoids, L-dopa, antiepileptics, nicotine, baclofen, SSRI, botulinum toxin).
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04294979
Start Date
February 1 2020
End Date
April 1 2024
Last Update
May 13 2025
Active Locations (1)
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1
IRCCS San Raffele Pisana
Roma, RM, Italy, 00166