Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
More Inclusion & Exclusion Criteria
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fondazione Don Carlo Gnocchi Onlus|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms & Interventions
Experimental: ToM training
ToM training was composed of six lessons two times a week. Through several types of stimuli, the trainer worked together with the participant to comprehend and hypothesize interpretations of the emotions and social interactions, providing discussion occasions to enhance the attribution of mental states and emotions. Every lesson had a duration of 45/60 minutes in order to avoid excessive fatigue in the participant.
Active Comparator: Non mentalistic training
ToM training was composed of six lessons two times a week. Through several types of stimuli, the trainer worked together with the participant to provide a historical and descriptive overview of cinema movies, TV news, documentaries, newspapers, and advertising. Every lesson had a duration of 45/60 minutes in order to avoid excessive fatigue in the participant.
Behavioral: - Rehabilitation training
Rehabilitation with behavioural stimuli
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.