nctId: NCT06328790 id: PNRR-MAD-2022-12376826 briefTitle: Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD) overallStatus: RECRUITING date: 2023-05-31 date: 2025-05 date: 2025-05 date: 2024-03-25 date: 2024-03-26 name: Michele Tinazzi, MD, PhD class: OTHER name: IRCCS Ospedale San Raffaele name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona 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. conditions: Functional Motor Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Multidisciplinary Rehabilitation Training name: Cross-sectional study on patients with FMD and patients with structural/organic diseases name: Cross-sectional study on patients with FMD and healthy controls (HC) measure: Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score measure: Multidimensional Fatigue Inventory Scale (MFI-20) score measure: Brief Pain Inventory (BPI) score measure: Beck Anxiety Inventory (BAI) score measure: Beck Depression Inventory (BDI-II) score measure: 12-item Short-Form Health Survey (SF-12) score measure: Toronto Alexithymia Scale (TAS-20) score measure: Direct adn indirect index of Sensory Attenuation (SA) measure: Joint angle at the elbow vibrated and reproduced measure: N2/P2 amplitude measure: Objective/Subjective heart rate ratio measure: Cortical thickness and gray matter volumes measure: Clinical Global Impression (CGI) score measure: Gait speed (cm/sec) measure: Swing time (%) measure: Stride time (s) measure: Stride length (cm) measure: Sway area (mm2) measure: Stance time (sec) measure: Total excursion path (mm) measure: Velocity of Cop displacement in the anteroposterior directions (mm/s) measure: Velocity of Cop displacement in the mediolateral directions (mm/s) measure: Autism spectrum Quotient (AQ) measure: Schizotypal Personality Questionnaire (SPQ) measure: Number of drop-out measure: Number of patients who refuse the treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona status: RECRUITING city: Salerno state: Campania zip: 84131 country: Italy name: Maria Teresa Pellecchia, PhD role: CONTACT phoneExt: +39 email: mpellecchia@unisa.it lat: 40.67545 lon: 14.79328 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milano state: Lombardia zip: 20132 country: Italy name: Federica Agosta, PhD role: CONTACT phoneExt: +39 email: agosta.federica@hsr.it name: Elisabetta Sarasso, PhD role: CONTACT email: sarasso.elisabetta@hsr.it lat: 45.46427 lon: 9.18951 facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona status: RECRUITING city: Verona zip: 37131 country: Italy name: Michele Tinazzi, PhD role: CONTACT phone: 0458124768 phoneExt: +39 email: michele.tinazzi@univr.it name: Marialuisa Gandolfi, PhD role: CONTACT phone: 3491656108 phoneExt: +39 email: marialuisa.gandolfi@univr.it lat: 45.4299 lon: 10.98444 hasResults: False