Status:
UNKNOWN
A ToM Training for People With Multiple Sclerosis: an Efficacy Study.
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Theory of Mind (ToM) is the ability to understand and attribute mental states to ourselves and others. People with Multiple Sclerosis (pwMS) could present an impairment of this ability, with negative ...
Eligibility Criteria
Inclusion
- diagnosis of Relapsing-Remitting (RR), Secondary Progressive (SP) and Primary Progressive (PP) MS;
- age ≥ 18 and ≤ 75 years;
- years of education ≥ 5;
- no change of pharmacological treatment in the 6 months before the enrollment;
- no clinical relapses or use of steroid treatment during 3 months before the enrollment;
- provided informed consent for study participation.
Exclusion
- history of nervous system disorders different from MS;
- unstable psychiatric illness, such as psychosis or major depression;
- severe disability with Expanded Disability Status Scale (EDSS) score \> 7.5;
- severe cognitive impairment that would not enable PwMS to answer to questionnaires correctly (i.e. dementia), according to the patient's medical records.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04711941
Start Date
February 1 2021
End Date
September 1 2021
Last Update
May 6 2021
Active Locations (1)
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1
IRCCS Fondazione Don Carlo Gnocchi
Milan, Italy