protocolSection identificationModule nctId: NCT06328790, orgStudyIdInfo id: PNRR-MAD-2022-12376826, briefTitle: Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-31, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Michele Tinazzi, MD, PhD, class: OTHER, collaborators name: IRCCS Ospedale San Raffaele, collaborators name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, descriptionModule briefSummary: Functional motor disorders (FMD) are prevalent and highly disabling conditions characterized by abnormal movements (functional weakness, tremor, dystonia) significantly altered by distractive manoeuvres and incongruent with movement disorders seen in specific neurological diseases. FMDs are still misunderstood, diagnosed with delay, and not adequately treated, leading to reduced independence and high healthcare costs. Symptoms are physiologically associated with voluntary movement (distractibility, resolution with placebo) but are reported as involuntary. How this happens is yet a matter of debate. Identifying diagnostic and prognostic disease-specific biomarkers is an unmet need. The investigators will investigate motor, exteroceptive and interoceptive domains in a large cohort of FMD patients by a comprehensive set of behavioural, neurophysiological, and MRI tests. Ad-hoc eXplainable Artificial Intelligence (XAI) methods will develop disease-specific diagnostic and prognostic biomarker algorithms., conditionsModule conditions: Functional Motor Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Multidisciplinary Rehabilitation Training, interventions name: Cross-sectional study on patients with FMD and patients with structural/organic diseases, interventions name: Cross-sectional study on patients with FMD and healthy controls (HC), outcomesModule primaryOutcomes measure: Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score, primaryOutcomes measure: Multidimensional Fatigue Inventory Scale (MFI-20) score, primaryOutcomes measure: Brief Pain Inventory (BPI) score, primaryOutcomes measure: Beck Anxiety Inventory (BAI) score, primaryOutcomes measure: Beck Depression Inventory (BDI-II) score, primaryOutcomes measure: 12-item Short-Form Health Survey (SF-12) score, primaryOutcomes measure: Toronto Alexithymia Scale (TAS-20) score, primaryOutcomes measure: Direct adn indirect index of Sensory Attenuation (SA), primaryOutcomes measure: Joint angle at the elbow vibrated and reproduced, primaryOutcomes measure: N2/P2 amplitude, primaryOutcomes measure: Objective/Subjective heart rate ratio, primaryOutcomes measure: Cortical thickness and gray matter volumes, primaryOutcomes measure: Clinical Global Impression (CGI) score, primaryOutcomes measure: Gait speed (cm/sec), primaryOutcomes measure: Swing time (%), primaryOutcomes measure: Stride time (s), primaryOutcomes measure: Stride length (cm), primaryOutcomes measure: Sway area (mm2), primaryOutcomes measure: Stance time (sec), primaryOutcomes measure: Total excursion path (mm), primaryOutcomes measure: Velocity of Cop displacement in the anteroposterior directions (mm/s), primaryOutcomes measure: Velocity of Cop displacement in the mediolateral directions (mm/s), primaryOutcomes measure: Autism spectrum Quotient (AQ), primaryOutcomes measure: Schizotypal Personality Questionnaire (SPQ), otherOutcomes measure: Number of drop-out, otherOutcomes measure: Number of patients who refuse the treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, status: RECRUITING, city: Salerno, state: Campania, zip: 84131, country: Italy, contacts name: Maria Teresa Pellecchia, PhD, role: CONTACT, phoneExt: +39, email: mpellecchia@unisa.it, geoPoint lat: 40.67545, lon: 14.79328, locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milano, state: Lombardia, zip: 20132, country: Italy, contacts name: Federica Agosta, PhD, role: CONTACT, phoneExt: +39, email: agosta.federica@hsr.it, contacts name: Elisabetta Sarasso, PhD, role: CONTACT, email: sarasso.elisabetta@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, status: RECRUITING, city: Verona, zip: 37131, country: Italy, contacts name: Michele Tinazzi, PhD, role: CONTACT, phone: 0458124768, phoneExt: +39, email: michele.tinazzi@univr.it, contacts name: Marialuisa Gandolfi, PhD, role: CONTACT, phone: 3491656108, phoneExt: +39, email: marialuisa.gandolfi@univr.it, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False