Investigating biomarkers and rehabilitation for functional motor disorders
A Window Into the Mind-brain-body Interplay: Development of Diagnostic, Prognostic Biomarkers and Rehabilitation Strategies in Functional Motor Disorders
This study is testing if new biological markers can help doctors better understand and treat people with functional motor disorders by comparing them to healthy individuals and those with other movement issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Locations | 3 sites (Salerno, Campania and 2 other locations) |
| Trial ID | NCT06328790 on ClinicalTrials.gov |
What this trial studies
This study focuses on functional motor disorders (FMD), which are characterized by abnormal movements that are often misunderstood and inadequately treated. The researchers aim to identify diagnostic and prognostic biomarkers by examining motor, exteroceptive, and interoceptive domains in a large cohort of FMD patients through behavioral, neurophysiological, and MRI tests. The study will also include comparisons with patients having structural/organic diseases and healthy controls. By utilizing explainable artificial intelligence methods, the study seeks to develop disease-specific biomarkers that could enhance understanding and treatment of FMD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinically definite diagnosis of functional motor disorders.
Not a fit: Patients with significant cognitive impairment, other neurological or psychiatric comorbidities, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with functional motor disorders.
How similar studies have performed: While the approach of identifying biomarkers in FMD is innovative, similar studies in related fields have shown promise in improving understanding and treatment of functional neurological disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Experiments 1 and 3 Inclusion Criteria for Patients with FMD: * Age higher or equal to 18 years * Clinically definite diagnosis of FMD Exclusion Criteria for Patients with FMD: * Mini-Mental State Examination score lower or equal to 24 * Physical impairment precluding signing the informed consent for participation * Certified other neurological and/or psychiatric comorbidities * Contraindications for 3T MRI Inclusion Criteria for Healthy Controls (HC) - Age higher or equal to 18 years Exclusion Criteria for Healthy Controls (HC) Mini-Mental State Examination score lower or equal to 24 * Physical impairment precluding signing the informed consent for participation * Certified neurological and/or psychiatric comorbidities * Contraindications for 3T MRI Experiment 2 Inclusion criteria * Age higher or equal to 18 years * Clinically definite diagnosis of "organic" motor disorders: weakness due to peripheral neuromuscular disorders, essential tremor, or idiopathic adult-onset dystonia. * Score\>2 on the Tremor Research Group Essential Tremor Rating Assessment Scale for patients with essential tremor * Rest tremors and other neurological signs * Current or past exposure to tremorgenic drugs Exclusion Criteria * Mini-Mental State Examination score lower or equal to 24 * Physical impairment precluding signing the informed consent for participation * Certified neurological and/or psychiatric comorbidities * Contraindications for 3T MRI
Where this trial is running
Salerno, Campania and 2 other locations
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona — Salerno, Campania, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milano, Lombardia, Italy (Recruiting)
- Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Michele Tinazzi, PhD — Universita di Verona
- Study coordinator: Michele Tinazzi, PhD
- Email: michele.tinazzi@univr.it
- Phone: 3480172554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.