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Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD)

NCT06328790 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2024-03-26

No results posted yet for this study

Summary

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

Interventions

OTHER

Multidisciplinary Rehabilitation Training

34 Patients will attend the in-person 5-day rehabilitation program (2 h/day) followed by a 12-weeks telemedicine program (1 h/week).

BEHAVIORAL

Cross-sectional study on patients with FMD and patients with structural/organic diseases

Each subject will undergo behavioural, neurophysiological, and Magnetic Resonance Imaging (MRI) tests exploring the motor, exteroceptive and interoceptive domains.

BEHAVIORAL

Cross-sectional study on patients with FMD and healthy controls (HC)

Each subject will undergo a set of behavioural, neurophysiological, and Magnetic Resonance Imaging (MRI) tests exploring the motor, exteroceptive and

Sponsors & Collaborators

  • IRCCS Ospedale San Raffaele

    collaborator OTHER

  • Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

    collaborator OTHER

  • Michele Tinazzi, MD, PhD

    lead OTHER

Principal Investigators

  • Michele Tinazzi, PhD · Universita di Verona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06328790 on ClinicalTrials.gov