Functional Motor DisordersNCT06328790

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

An observational study of Functional Motor Disorders, run by Michele Tinazzi, MD, PhD at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Functional Motor Disorders
What is being tested?: Multidisciplinary Rehabilitation Training and Cross-sectional study on patients with FMD and patients with structural/organic diseases
Type of treatment: Lifestyle or therapy programme
How many people: 450 participants
Where: 3 sitesItaly
Study dates: 31 May 2023to May 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Experiments 1 and 3: Functional Motor Disorders Experiment 2: patients with "organic" motor disorders (weakness due to peripheral neuromuscular disorders, essential tremor, or idiopathic adult-onset dystonia)

Who may be able to join

Age higher or equal to 18 years
Clinically definite diagnosis of FMD
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

Show all 13Show fewer

Contraindications for 3T MRI
Experiment 2
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

Who cannot join

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
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

Trial locations and contacts

3 sites in 1 country.

Michele Tinazzi, PhD contact

3480172554 ext. +39

michele.tinazzi@univr.it

Marialuisa Gandolfi, PhD contact

3491656108 ext. +39

marialuisa.gandolfi@univr.it

Italy3 sites, 3 recruiting

IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Federica Agosta, PhD, agosta.federica@hsr.it
Elisabetta Sarasso, PhD, sarasso.elisabetta@hsr.it
Recruiting
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Campania, 84131
Maria Teresa Pellecchia, PhD, mpellecchia@unisa.it
Recruiting
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Verona, 37131
Michele Tinazzi, PhD, 0458124768 ext. +39, michele.tinazzi@univr.it
Marialuisa Gandolfi, PhD, 3491656108 ext. +39, marialuisa.gandolfi@univr.it
Recruiting

Other trials in Italy

About this study

Official title: A Window Into the Mind-brain-body Interplay: Development of Diagnostic, Prognostic Biomarkers and Rehabilitation Strategies in Functional Motor Disorders

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.

Read the detailed description

Functional motor disorders (FMD) are part of the broad spectrum of functional neurological disorders characterized by abnormal movements (functional limb weakness, tremor, dystonia) significantly altered by distractive manoeuvres and incongruent with movement disorders seen in specific neurological diseases. FMDs have a high prevalence, are still misunderstood, diagnosed with a long delay, and not adequately treated, leading to high degrees of disability and poor quality of life with increasing social and economic costs. The old concept of psychological factors as the primary cause (conversion disorder) has been abandoned due to the lack of evidence about their causal role. According to a predictive coding account, the emerging idea is that symptoms and disability in FMD may depend on dysfunctions of a specific neural system integrating interoception, exteroception, and motor control. The idea underpins the investigator's proposal that FMD symptoms are perceptions of the state of the body. Besides the main pathophysiological features (abnormal attentional focus, beliefs/expectations, and sense of agency), the lived experience of symptoms and their resulting disability may depend on a specific neural system integrating motor, exteroceptive and interoceptive domains. Therefore, dysfunction within this system can cause and sustain motor and non-motor symptoms in FMD. Three-stage research will be conducted. A large cohort of patients with a definite diagnosis of FMD (n=150) and healthy controls (n=150) will be investigated by behavioural, neurophysiological, and MRI tests to collect biomarkers in the motor, exteroceptive and interoceptive domains. Computational modelling of the behavioural, neurophysiological, and MRI biomarkers will be developed through eXplainable Artificial Intelligence (XAI) methods through a data mining approach (machine learning) to implement a diagnostic algorithm biomarker (objective 1). A cohort of patients with "organic" motor disorders (n=75) will undergo the same behavioural, neurophysiological, and MRI tests belonging to the resulting biomarker-based diagnostic algorithm for validation (objective 2). Finally, the modulation of the resulting biomarker-based diagnostic algorithm after rehabilitation and the correlations of motor and non-motor symptoms (NMSs) with clinical improvement will be investigated in a sub-group of patients with FMD to explore the predictive value (objective 3). Our proposal consists of 6 work packages (WP), all integrated to deliver our stated objectives over the project's lifetime to achieve these objectives. Communication and dissemination activities will include the project's visual identity, public website, social media, videos, and press releases. Our proposal will inform the research and clinical community on disease-specific biomarkers for diagnosing and prognosis patients with FMD. The proposed approach has significant potential to disentangle some of the poorly understood features of these disorders, potentially providing a platform for more fundamental insights into brain functioning and the development of precision medicine approaches in their management. The proposed approach can also give the clinicians validated examinations to make a correct early diagnosis. This will improve the management of FMD with a positive impact on the patient's disability and the socio-economic costs of the illness.

Conditions: Functional Motor Disorders
Being tested: Multidisciplinary Rehabilitation Training, Cross-sectional study on patients with FMD and patients with structural/organic diseases, Cross-sectional study on patients with FMD and healthy controls (HC)
Keywords: Non motor symptoms, Motor symptoms, Exteroception, Interoception, Neurophysiological, MRI assessment, Diagnosis, Behavioral
Medical subject headings: Disease, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multidisciplinary Rehabilitation TrainingOther
Also called Experiment 3
34 Patients will attend the in-person 5-day rehabilitation program (2 h/day) followed by a 12-weeks telemedicine program (1 h/week).
Cross-sectional study on patients with FMD and patients with structural/organic diseasesBehavioural
Also called Experiment 2
Each subject will undergo behavioural, neurophysiological, and Magnetic Resonance Imaging (MRI) tests exploring the motor, exteroceptive and interoceptive domains.
Cross-sectional study on patients with FMD and healthy controls (HC)Behavioural
Also called Experiment 1
Each subject will undergo a set of behavioural, neurophysiological, and Magnetic Resonance Imaging (MRI) tests exploring the motor, exteroceptive and

Study groups in NCT06328790
Study group	Role	What they receive
Functional Motor Disorder rehabilitation group (FMD)		Patients with FMD (subject to current diagnostic criteria) will undergo experiment 3. Receives: Other: Multidisciplinary Rehabilitation Training
Healthy Controls group (HC)		Healthy subjects at least 18 years old will undergo experiment 1. Receives: Behavioral: Cross-sectional study on patients with FMD and healthy controls (HC)
"Organic" Motor Disorders group		Patients with "organic" motor disorders (weakness due to peripheral neuromuscular disorders, essential tremor, or idiopathic adult-onset dystonia, all according to current diagnostic criteria) will undergo experiment 2. Receives: Behavioral: Cross-sectional study on patients with FMD and patients with structural/organic diseases
Functional Motor Disorder group (FMD)		Patients with FMD (subject to current diagnostic criteria) will undergo experiment 1. Receives: Behavioral: Cross-sectional study on patients with FMD and healthy controls (HC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Multidimensional Fatigue Inventory Scale (MFI-20) score
It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Brief Pain Inventory (BPI) score
It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Beck Anxiety Inventory (BAI) score
It evaluates anxiety (range: 0-63; higher = worse).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Beck Depression Inventory (BDI-II) score
It evaluates depression (range: 0-63; higher = worse).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
12-item Short-Form Health Survey (SF-12) score
The health-Related QoL will be evaluated by the Mental Health and Physical functioning of the 12-item Short-Form Health Survey (SF-12) (range: 0-100; higher = better).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Toronto Alexithymia Scale (TAS-20) score
It evaluates the level of alexithymia (range: 20-100; higher = worse).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Direct adn indirect index of Sensory Attenuation (SA)
Sensory attenuation (SA) will be used to collect data
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Joint angle at the elbow vibrated and reproduced
Tonic vibration reflex (TVR) will be used to collect data
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
N2/P2 amplitude
Laser evoked potentials (LEP) will be used to collect data
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Objective/Subjective heart rate ratio
Heartbeat Perception Task (HPT) will be used to collect data
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Cortical thickness and gray matter volumes
Brain 3 Tesla MRI will be used to collect data
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Clinical Global Impression (CGI) score
Self-rated perception of change will be assessed with the 7-point Clinical Global Impression (CGI) scale with scores from 1 (very much improved) to 7 (very much worse).
Measured: After 3 months of the intensive 5-day rehabilitation protocol (T1).
Gait speed (cm/sec)
Gait analysis will be used to collect gait speed (cm/s).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Swing time (%)
Gait analysis will be used to collect swing time (%).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Stride time (s)
Gait analysis will be used to collect stride time (s).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Stride length (cm)
Gait analysis will be used to collect stride length (cm).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Sway area (mm2)
An electronic monaxial stabilometric platform will be used to collect sway area (mm2).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Stance time (sec)
An electronic monaxial stabilometric platform will be used to collect stance time (sec).
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Total excursion path (mm)
An electronic monaxial stabilometric platform will be used to collect total excursion path (mm): area of oscillations of the Center of Pressure (CoP), CoP perimeter length
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Velocity of Cop displacement in the anteroposterior directions (mm/s)
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the anteroposterior directions.
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Velocity of Cop displacement in the mediolateral directions (mm/s)
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the mediolateral directions.
Measured: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Autism spectrum Quotient (AQ)
It is a 50-item self-report measure used to assess traits of autism in adults and adolescents aged 16 years and over (Total score: 0-50; cut-off: > 29).
Measured: Before the intensive 5-day rehabilitation protocol (T0)
Schizotypal Personality Questionnaire (SPQ)
It is a scale for the assessment of schizotypal personality based on DSM-III-R criteria (Total score: 0-74; cut-off: < 8 \& > 42).
Measured: Before the intensive 5-day rehabilitation protocol (T0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 2023May 2025

First posted25 Mar 2024
Study start31 May 2023
Primary completionMay 2025 (estimated)
Study completionMay 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Functional Motor DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 450 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06328790
Sponsor's protocol ID: PNRR-MAD-2022-12376826
Status last verified: Mar 2024
First submitted: 18 Mar 2024
Last updated: 26 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol. 2009 Aug;22(4):430-6. doi: 10.1097/WCO.0b013e32832dc169.
PubMed 19542886
Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.
PubMed 29193359
Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.
PubMed 23649720
Engel AG, Myology, vol.II, 3rd ed. New York:McGraw-Hill;2004
Piramide N, Agosta F, Sarasso E, Canu E, Volonte MA, Filippi M. Brain activity during lower limb movements in Parkinson's disease patients with and without freezing of gait. J Neurol. 2020 Apr;267(4):1116-1126. doi: 10.1007/s00415-019-09687-1. Epub 2020 Jan 2.
PubMed 31897599
Cojan Y, Waber L, Carruzzo A, Vuilleumier P. Motor inhibition in hysterical conversion paralysis. Neuroimage. 2009 Sep;47(3):1026-37. doi: 10.1016/j.neuroimage.2009.05.023. Epub 2009 May 18.
PubMed 19450695
Tinazzi M, Morgante F, Marcuzzo E, Erro R, Barone P, Ceravolo R, Mazzucchi S, Pilotto A, Padovani A, Romito LM, Eleopra R, Zappia M, Nicoletti A, Dallocchio C, Arbasino C, Bono F, Pascarella A, Demartini B, Gambini O, Modugno N, Olivola E, Di Stefano V, Albanese A, Ferrazzano G, Tessitore A, Zibetti M, Calandra-Buonaura G, Petracca M, Esposito M, Pisani A, Manganotti P, Stocchi F, Coletti Moja M, Antonini A, Defazio G, Geroin C. Clinical Correlates of Functional Motor Disorders: An Italian Multicenter Study. Mov Disord Clin Pract. 2020 Sep 22;7(8):920-929. doi: 10.1002/mdc3.13077. eCollection 2020 Nov.
PubMed 33163563
Gandolfi M, Riello M, Bellamoli V, Bombieri F, Geroin C, Di Vico IA, Tinazzi M. Motor and non-motor outcomes after a rehabilitation program for patients with Functional Motor Disorders: A prospective, observational cohort study. NeuroRehabilitation. 2021;48(3):305-314. doi: 10.3233/NRE-201617.
PubMed 33780378
Tomic A, Agosta F, Sarasso E, Petrovic I, Basaia S, Pesic D, Kostic M, Fontana A, Kostic VS, Filippi M. Are there two different forms of functional dystonia? A multimodal brain structural MRI study. Mol Psychiatry. 2020 Dec;25(12):3350-3359. doi: 10.1038/s41380-018-0222-2. Epub 2018 Aug 17.
PubMed 30120414
Canu E, Agosta F, Tomic A, Sarasso E, Petrovic I, Piramide N, Svetel M, Inuggi A, D Miskovic N, Kostic VS, Filippi M. Breakdown of the affective-cognitive network in functional dystonia. Hum Brain Mapp. 2020 Aug 1;41(11):3059-3076. doi: 10.1002/hbm.24997. Epub 2020 Apr 3.
PubMed 32243055
Piramide N, Sarasso E, Tomic A, Canu E, Petrovic IN, Svetel M, Basaia S, Dragasevic Miskovic N, Kostic VS, Filippi M, Agosta F. Functional MRI connectivity of the primary motor cortex in functional dystonia patients. J Neurol. 2022 Jun;269(6):2961-2971. doi: 10.1007/s00415-021-10879-x. Epub 2021 Nov 12.
PubMed 34773159
Landolfi A, Ricciardi C, Donisi L, Cesarelli G, Troisi J, Vitale C, Barone P, Amboni M. Machine Learning Approaches in Parkinson's Disease. Curr Med Chem. 2021;28(32):6548-6568. doi: 10.2174/0929867328999210111211420.
PubMed 33430721
Teodoro T, Koreki A, Meppelink AM, Little S, Nielsen G, Macerollo A, Ferreira JJ, Parees I, Lang A, Edwards MJ. Contingent negative variation: a biomarker of abnormal attention in functional movement disorders. Eur J Neurol. 2020 Jun;27(6):985-994. doi: 10.1111/ene.14189. Epub 2020 Apr 14.
PubMed 32096289
Lorenz J, Garcia-Larrea L. Contribution of attentional and cognitive factors to laser evoked brain potentials. Neurophysiol Clin. 2003 Dec;33(6):293-301. doi: 10.1016/j.neucli.2003.10.004.
PubMed 14678843
Hanzlikova Z, Kofler M, Slovak M, Vechetova G, Fecikova A, Kemlink D, Sieger T, Ruzicka E, Valls-Sole J, Edwards MJ, Serranova T. Prepulse inhibition of the blink reflex is abnormal in functional movement disorders. Mov Disord. 2019 Jul;34(7):1022-1030. doi: 10.1002/mds.27706. Epub 2019 May 2.
PubMed 31046188

Want to know more?

Michele Tinazzi, PhD

3480172554 ext. +39

michele.tinazzi@univr.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Functional Motor Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Window Into the Mind-brain-body Interplay: Development of Diagnostic, Prognostic Biomarkers and Rehabilitation Strategies in Functional Motor Disorders
ClinicalTrials.gov ID: NCT06328790
Acronym / sponsor ID: PNRR-MAD-2022-12376826
Conditions: Functional Motor Disorders
Keywords: Non motor symptoms, Motor symptoms, Exteroception, Interoception, Neurophysiological, MRI assessment, Diagnosis, Behavioral
Study type: Observational
Recruitment status: Unknown status
Enrolment: 450 participants (estimated)
Lead sponsor: Michele Tinazzi, MD, PhDUniversity, hospital or other
Collaborators: IRCCS Ospedale San Raffaele, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Study start: 31 May 2023 (actual)
Primary completion: May 2025 (estimated)
Study completion: May 2025 (estimated)
First posted: 25 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Functional Motor Disorder rehabilitation group (FMD)	–	Other: Multidisciplinary Rehabilitation TrainingPatients with FMD (subject to current diagnostic criteria) will undergo experiment 3.
Healthy Controls group (HC)	–	Behavioral: Cross-sectional study on patients with FMD and healthy controls (HC)Healthy subjects at least 18 years old will undergo experiment 1.
"Organic" Motor Disorders group	–	Behavioral: Cross-sectional study on patients with FMD and patients with structural/organic diseasesPatients with "organic" motor disorders (weakness due to peripheral neuromuscular disorders, essential tremor, or idiopathic adult-onset dystonia, all according to current diagnostic criteria) will undergo experiment 2.
Functional Motor Disorder group (FMD)	–	Behavioral: Cross-sectional study on patients with FMD and healthy controls (HC)Patients with FMD (subject to current diagnostic criteria) will undergo experiment 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Experiments 1 and 3: Functional Motor Disorders Experiment 2: patients with "organic" motor disorders (weakness due to peripheral neuromuscular disorders, essential tremor, or idiopathic adult-onset dystonia)

Key inclusion criteria (13 listed)

Age higher or equal to 18 years
Clinically definite diagnosis of FMD
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

Key exclusion criteria (8 listed)

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
Mini-Mental State Examination score lower or equal to 24

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multidisciplinary Rehabilitation TrainingAlso: Experiment 334 Patients will attend the in-person 5-day rehabilitation program (2 h/day) followed by a 12-weeks telemedicine program (1 h/week).	Other	Functional Motor Disorder rehabilitation group (FMD)
Cross-sectional study on patients with FMD and patients with structural/organic diseasesAlso: Experiment 2Each subject will undergo behavioural, neurophysiological, and Magnetic Resonance Imaging (MRI) tests exploring the motor, exteroceptive and interoceptive domains.	Behavioural	"Organic" Motor Disorders group
Cross-sectional study on patients with FMD and healthy controls (HC)Also: Experiment 1Each subject will undergo a set of behavioural, neurophysiological, and Magnetic Resonance Imaging (MRI) tests exploring the motor, exteroceptive and	Behavioural	Functional Motor Disorder group (FMD), Healthy Controls group (HC)

Primary outcome

Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse).
Multidimensional Fatigue Inventory Scale (MFI-20) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse).
Brief Pain Inventory (BPI) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).
Beck Anxiety Inventory (BAI) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
It evaluates anxiety (range: 0-63; higher = worse).
Beck Depression Inventory (BDI-II) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
It evaluates depression (range: 0-63; higher = worse).
12-item Short-Form Health Survey (SF-12) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
The health-Related QoL will be evaluated by the Mental Health and Physical functioning of the 12-item Short-Form Health Survey (SF-12) (range: 0-100; higher = better).
Toronto Alexithymia Scale (TAS-20) score
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
It evaluates the level of alexithymia (range: 20-100; higher = worse).
Direct adn indirect index of Sensory Attenuation (SA)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Sensory attenuation (SA) will be used to collect data
Joint angle at the elbow vibrated and reproduced
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Tonic vibration reflex (TVR) will be used to collect data
N2/P2 amplitude
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Laser evoked potentials (LEP) will be used to collect data
Objective/Subjective heart rate ratio
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Heartbeat Perception Task (HPT) will be used to collect data
Cortical thickness and gray matter volumes
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Brain 3 Tesla MRI will be used to collect data
Clinical Global Impression (CGI) score
Time frame: After 3 months of the intensive 5-day rehabilitation protocol (T1).
Self-rated perception of change will be assessed with the 7-point Clinical Global Impression (CGI) scale with scores from 1 (very much improved) to 7 (very much worse).
Gait speed (cm/sec)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Gait analysis will be used to collect gait speed (cm/s).
Swing time (%)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Gait analysis will be used to collect swing time (%).
Stride time (s)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Gait analysis will be used to collect stride time (s).
Stride length (cm)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
Gait analysis will be used to collect stride length (cm).
Sway area (mm2)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
An electronic monaxial stabilometric platform will be used to collect sway area (mm2).
Stance time (sec)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
An electronic monaxial stabilometric platform will be used to collect stance time (sec).
Total excursion path (mm)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
An electronic monaxial stabilometric platform will be used to collect total excursion path (mm): area of oscillations of the Center of Pressure (CoP), CoP perimeter length
Velocity of Cop displacement in the anteroposterior directions (mm/s)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the anteroposterior directions.
Velocity of Cop displacement in the mediolateral directions (mm/s)
Time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the mediolateral directions.
Autism spectrum Quotient (AQ)
Time frame: Before the intensive 5-day rehabilitation protocol (T0)
It is a 50-item self-report measure used to assess traits of autism in adults and adolescents aged 16 years and over (Total score: 0-50; cut-off: > 29).
Schizotypal Personality Questionnaire (SPQ)
Time frame: Before the intensive 5-day rehabilitation protocol (T0)
It is a scale for the assessment of schizotypal personality based on DSM-III-R criteria (Total score: 0-74; cut-off: < 8 \& > 42).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Background: PubMed 19542886Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol. 2009 Aug;22(4):430-6. doi: 10.1097/WCO.0b013e32832dc169.
Background: PubMed 29193359Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.
Background: PubMed 23649720Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.
BackgroundEngel AG, Myology, vol.II, 3rd ed. New York:McGraw-Hill;2004
Background: PubMed 31897599Piramide N, Agosta F, Sarasso E, Canu E, Volonte MA, Filippi M. Brain activity during lower limb movements in Parkinson's disease patients with and without freezing of gait. J Neurol. 2020 Apr;267(4):1116-1126. doi: 10.1007/s00415-019-09687-1. Epub 2020 Jan 2.
Background: PubMed 19450695Cojan Y, Waber L, Carruzzo A, Vuilleumier P. Motor inhibition in hysterical conversion paralysis. Neuroimage. 2009 Sep;47(3):1026-37. doi: 10.1016/j.neuroimage.2009.05.023. Epub 2009 May 18.
Background: PubMed 33163563Tinazzi M, Morgante F, Marcuzzo E, Erro R, Barone P, Ceravolo R, Mazzucchi S, Pilotto A, Padovani A, Romito LM, Eleopra R, Zappia M, Nicoletti A, Dallocchio C, Arbasino C, Bono F, Pascarella A, Demartini B, Gambini O, Modugno N, Olivola E, Di Stefano V, Albanese A, Ferrazzano G, Tessitore A, Zibetti M, Calandra-Buonaura G, Petracca M, Esposito M, Pisani A, Manganotti P, Stocchi F, Coletti Moja M, Antonini A, Defazio G, Geroin C. Clinical Correlates of Functional Motor Disorders: An Italian Multicenter Study. Mov Disord Clin Pract. 2020 Sep 22;7(8):920-929. doi: 10.1002/mdc3.13077. eCollection 2020 Nov.
Background: PubMed 33780378Gandolfi M, Riello M, Bellamoli V, Bombieri F, Geroin C, Di Vico IA, Tinazzi M. Motor and non-motor outcomes after a rehabilitation program for patients with Functional Motor Disorders: A prospective, observational cohort study. NeuroRehabilitation. 2021;48(3):305-314. doi: 10.3233/NRE-201617.
Background: PubMed 30120414Tomic A, Agosta F, Sarasso E, Petrovic I, Basaia S, Pesic D, Kostic M, Fontana A, Kostic VS, Filippi M. Are there two different forms of functional dystonia? A multimodal brain structural MRI study. Mol Psychiatry. 2020 Dec;25(12):3350-3359. doi: 10.1038/s41380-018-0222-2. Epub 2018 Aug 17.
Background: PubMed 32243055Canu E, Agosta F, Tomic A, Sarasso E, Petrovic I, Piramide N, Svetel M, Inuggi A, D Miskovic N, Kostic VS, Filippi M. Breakdown of the affective-cognitive network in functional dystonia. Hum Brain Mapp. 2020 Aug 1;41(11):3059-3076. doi: 10.1002/hbm.24997. Epub 2020 Apr 3.
Background: PubMed 34773159Piramide N, Sarasso E, Tomic A, Canu E, Petrovic IN, Svetel M, Basaia S, Dragasevic Miskovic N, Kostic VS, Filippi M, Agosta F. Functional MRI connectivity of the primary motor cortex in functional dystonia patients. J Neurol. 2022 Jun;269(6):2961-2971. doi: 10.1007/s00415-021-10879-x. Epub 2021 Nov 12.
Background: PubMed 33430721Landolfi A, Ricciardi C, Donisi L, Cesarelli G, Troisi J, Vitale C, Barone P, Amboni M. Machine Learning Approaches in Parkinson's Disease. Curr Med Chem. 2021;28(32):6548-6568. doi: 10.2174/0929867328999210111211420.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michele Tinazzi, PhD contact

3480172554 ext. +39

michele.tinazzi@univr.it

Marialuisa Gandolfi, PhD contact

3491656108 ext. +39

marialuisa.gandolfi@univr.it

Michele Tinazzi, PhD principal investigator

Universita di Verona

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Functional Motor Disorders, run by Michele Tinazzi, MD, PhD at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michele Tinazzi, PhD (3480172554 ext. +39, michele.tinazzi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score (time frame: Before the intensive 5-day rehabilitation protocol (T0) and after 3 months of the intensive 5-day rehabilitation protocol (T1).). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06328790, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.