Observational Study on "Functional Overlay" in Patients With Movement Disorders

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05943652

Collaborator

(none)

216

Enrollment

Location

41.9

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about functional neurological disorders in patients with common non-functional movement disorders ("functional overlay"). The main questions it aims to answer are:

What is the frequency of functional neurological disorders in patients with non-functional movement disorders (functional overlay)?
What are the characteristics of functional neurological disorders in patients with non-functional movement disorders?

Participants will be examined clinically and electrophysiologically, the examinations consist of:

a neurological examination
neuropsychological testing
electrophysiological tremor diagnostic
questionnaires about psychological, biological and social risk factors

Researchers will compare patients with functional motor disorders to patients wit non-functional movement disorders to see if they differ from each other regarding the functional symptoms.

Condition or Disease	Intervention/Treatment	Phase
Conversion Disorder Parkinson Disease Tremor Dystonia	Diagnostic Test: Neurological examination Diagnostic Test: Anamnesis Diagnostic Test: Neuropsychological testing Diagnostic Test: Questionnaires Diagnostic Test: Tremor recording

Detailed Description

Functional neurological disorders (FND) are common neurological disorders that are present in up to 16% of patients in neurological outpatient clinics. They are associated with a significant reduction in quality of life, can lead to permanent impairment, and have a poor prognosis, especially if the diagnosis is delayed.

FND have multifactorial causes and risk factors, including psychological stressors, childhood trauma, female gender, psychiatric disorders such as depression, anxiety disorder, or post-traumatic stress disorder, and other functional disorders such as irritable bowel syndrome or chronic pain syndrome. Patients with FND often report additional cognitive complaints ("cognitive fog").

A mismatch of various regulatory mechanisms, a disruption of sensory processing and motor output is assumed to be a central part of the pathogenesis. A characteristic feature of FND is a variability of symptoms according to attention. FND can be intensified by increased attention and weakened by distraction. Positive diagnostic criteria for FND have been established recently, so that by definition FND are no longer a diagnosis of exclusion.

The clinical presentations of FND are diverse and include impaired limb movement control, disturbances in vigilance that may be associated with seizures, and non-motor symptoms. FND often coincide and often coexist with pain, fatigue, sleep disorders, and cognitive disorders. Particularly non-motor functional symptoms are highly debilitating for patients.

The coincidence of "organic" neurological disorders and FND in the same patients ("functional overlay") is probably not uncommon, but has been investigated primarily in patients with Parkinson's Disease and epilepsy, so far. However, it is important to recognize FND in patients with movement disorders in order to treat them adequately and to protect them from incorrect treatment (surgery, unnecessary medication, etc.). However, the basic prerequisite for this is an exploration of the frequency and characteristics of the functional symptoms in movement disorders.

Study Design

Study Type:

Observational

Anticipated Enrollment :

216 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Prevalence and Clinical Presentation of Functional Neurological Disorders in Patients With Movement Disorders - A Cross-sectional Study in the Movement Disorders Clinic of the Department of Neurology, Medical University of Graz

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Parkinson Disease	Diagnostic Test: Neurological examination A neurological examination following a protocol to detect positive signs of functional neurological disorders. Diagnostic Test: Anamnesis A standardized question about the patient´s history. The response time is measured. Question: "Could you tell me about the problems with the movement disorder you are experiencing?" Diagnostic Test: Neuropsychological testing Neuropsychological cognitive testing including: Montreal Cognitive Assessment (MOCA) Rey-Osterrieth Complex Figure Test (ROCFT) Wechsler Memory Scale IV Comprehensive Trail Making Test (CTMT) semantic and phonematic fluency tests Diagnostic Test: Questionnaires Short Form 36 (SF 36) Somatic Symptom Disorder - B Criteria Scale (SSD 12) Patient Health Questionnaire 9 (PHQ 9) Patient Health Questionnaire 15 (PHQ 15) Generalized Anxiety Disorder 7 (GAD 7) Fatigue Severity Scale (FSS) Psychosomatic Competence Inventory (PSCI) Work Ability Index (WAI) Level of Personality Functioning Scale Toronto Alexithymia Scale Levels of Emotional Awareness Scale (short version) Certainty About Mental States Questionnaire Somatosensoric Amplification Scale Personality Inventory for DSM-5 short version (PID5BF+M) Childhood Trauma Questionnaire European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) Diagnostic Test: Tremor recording Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Idiopathic Dystonia	Diagnostic Test: Neurological examination A neurological examination following a protocol to detect positive signs of functional neurological disorders. Diagnostic Test: Anamnesis A standardized question about the patient´s history. The response time is measured. Question: "Could you tell me about the problems with the movement disorder you are experiencing?" Diagnostic Test: Neuropsychological testing Neuropsychological cognitive testing including: Montreal Cognitive Assessment (MOCA) Rey-Osterrieth Complex Figure Test (ROCFT) Wechsler Memory Scale IV Comprehensive Trail Making Test (CTMT) semantic and phonematic fluency tests Diagnostic Test: Questionnaires Short Form 36 (SF 36) Somatic Symptom Disorder - B Criteria Scale (SSD 12) Patient Health Questionnaire 9 (PHQ 9) Patient Health Questionnaire 15 (PHQ 15) Generalized Anxiety Disorder 7 (GAD 7) Fatigue Severity Scale (FSS) Psychosomatic Competence Inventory (PSCI) Work Ability Index (WAI) Level of Personality Functioning Scale Toronto Alexithymia Scale Levels of Emotional Awareness Scale (short version) Certainty About Mental States Questionnaire Somatosensoric Amplification Scale Personality Inventory for DSM-5 short version (PID5BF+M) Childhood Trauma Questionnaire European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) Diagnostic Test: Tremor recording Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Essential Tremor	Diagnostic Test: Neurological examination A neurological examination following a protocol to detect positive signs of functional neurological disorders. Diagnostic Test: Anamnesis A standardized question about the patient´s history. The response time is measured. Question: "Could you tell me about the problems with the movement disorder you are experiencing?" Diagnostic Test: Neuropsychological testing Neuropsychological cognitive testing including: Montreal Cognitive Assessment (MOCA) Rey-Osterrieth Complex Figure Test (ROCFT) Wechsler Memory Scale IV Comprehensive Trail Making Test (CTMT) semantic and phonematic fluency tests Diagnostic Test: Questionnaires Short Form 36 (SF 36) Somatic Symptom Disorder - B Criteria Scale (SSD 12) Patient Health Questionnaire 9 (PHQ 9) Patient Health Questionnaire 15 (PHQ 15) Generalized Anxiety Disorder 7 (GAD 7) Fatigue Severity Scale (FSS) Psychosomatic Competence Inventory (PSCI) Work Ability Index (WAI) Level of Personality Functioning Scale Toronto Alexithymia Scale Levels of Emotional Awareness Scale (short version) Certainty About Mental States Questionnaire Somatosensoric Amplification Scale Personality Inventory for DSM-5 short version (PID5BF+M) Childhood Trauma Questionnaire European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) Diagnostic Test: Tremor recording Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Functional Neurological Disorder	Diagnostic Test: Neurological examination A neurological examination following a protocol to detect positive signs of functional neurological disorders. Diagnostic Test: Anamnesis A standardized question about the patient´s history. The response time is measured. Question: "Could you tell me about the problems with the movement disorder you are experiencing?" Diagnostic Test: Neuropsychological testing Neuropsychological cognitive testing including: Montreal Cognitive Assessment (MOCA) Rey-Osterrieth Complex Figure Test (ROCFT) Wechsler Memory Scale IV Comprehensive Trail Making Test (CTMT) semantic and phonematic fluency tests Diagnostic Test: Questionnaires Short Form 36 (SF 36) Somatic Symptom Disorder - B Criteria Scale (SSD 12) Patient Health Questionnaire 9 (PHQ 9) Patient Health Questionnaire 15 (PHQ 15) Generalized Anxiety Disorder 7 (GAD 7) Fatigue Severity Scale (FSS) Psychosomatic Competence Inventory (PSCI) Work Ability Index (WAI) Level of Personality Functioning Scale Toronto Alexithymia Scale Levels of Emotional Awareness Scale (short version) Certainty About Mental States Questionnaire Somatosensoric Amplification Scale Personality Inventory for DSM-5 short version (PID5BF+M) Childhood Trauma Questionnaire European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) Diagnostic Test: Tremor recording Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Functional Cognitive Disorder	Diagnostic Test: Neurological examination A neurological examination following a protocol to detect positive signs of functional neurological disorders. Diagnostic Test: Anamnesis A standardized question about the patient´s history. The response time is measured. Question: "Could you tell me about the problems with the movement disorder you are experiencing?" Diagnostic Test: Neuropsychological testing Neuropsychological cognitive testing including: Montreal Cognitive Assessment (MOCA) Rey-Osterrieth Complex Figure Test (ROCFT) Wechsler Memory Scale IV Comprehensive Trail Making Test (CTMT) semantic and phonematic fluency tests Diagnostic Test: Questionnaires Short Form 36 (SF 36) Somatic Symptom Disorder - B Criteria Scale (SSD 12) Patient Health Questionnaire 9 (PHQ 9) Patient Health Questionnaire 15 (PHQ 15) Generalized Anxiety Disorder 7 (GAD 7) Fatigue Severity Scale (FSS) Psychosomatic Competence Inventory (PSCI) Work Ability Index (WAI) Level of Personality Functioning Scale Toronto Alexithymia Scale Levels of Emotional Awareness Scale (short version) Certainty About Mental States Questionnaire Somatosensoric Amplification Scale Personality Inventory for DSM-5 short version (PID5BF+M) Childhood Trauma Questionnaire European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) Diagnostic Test: Tremor recording Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Alzheimer Disease	Diagnostic Test: Neurological examination A neurological examination following a protocol to detect positive signs of functional neurological disorders. Diagnostic Test: Anamnesis A standardized question about the patient´s history. The response time is measured. Question: "Could you tell me about the problems with the movement disorder you are experiencing?" Diagnostic Test: Neuropsychological testing Neuropsychological cognitive testing including: Montreal Cognitive Assessment (MOCA) Rey-Osterrieth Complex Figure Test (ROCFT) Wechsler Memory Scale IV Comprehensive Trail Making Test (CTMT) semantic and phonematic fluency tests Diagnostic Test: Questionnaires Short Form 36 (SF 36) Somatic Symptom Disorder - B Criteria Scale (SSD 12) Patient Health Questionnaire 9 (PHQ 9) Patient Health Questionnaire 15 (PHQ 15) Generalized Anxiety Disorder 7 (GAD 7) Fatigue Severity Scale (FSS) Psychosomatic Competence Inventory (PSCI) Work Ability Index (WAI) Level of Personality Functioning Scale Toronto Alexithymia Scale Levels of Emotional Awareness Scale (short version) Certainty About Mental States Questionnaire Somatosensoric Amplification Scale Personality Inventory for DSM-5 short version (PID5BF+M) Childhood Trauma Questionnaire European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) Diagnostic Test: Tremor recording Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)

Outcome Measures

Primary Outcome Measures

Functional neurological symptoms [on average 30 minutes]
Diagnosed by positive signs for functional neurological symptoms, as assessed in the neurological examination

Secondary Outcome Measures

Duration of anamnesis [1 to 3 minutes]
Duration in seconds of the response to the question: "Could you tell me about the problems with the movement disorder you are experiencing?"
Tremor diagnostic [up to 20 minutes]
Sum score of a electrophysiological test battery for psychogenic tremor, a scale from 0 to 10 with higher numbers indicating a higher probability for functional tremor
Subjective quality of life [5 minutes]
European Quality of Life 5 Dimensions 5 Level Version (EQ 5D 5L), results in a 5-digit number that describes the patient's health state
Subjective health [up to 10 minutes]
Short Form 36 Questionnaire (SF-36), a 36 items questionnaires that results in 8 scales that describe the subjective health state of the patient, higher values indicating better health
Fatigue [up to 5 minutes]
Fatigue severity scale (FSS): 9 item questionnaire with a 7 point Likert scale, higher values indicating more fatigue
General anxiety [3 minutes]
General anxiety disorder scale 7 (GAD-7): a 7 items questionnaire (0 to 21 points, higher values indicating more anxiety)
Somatic symptoms [5 minutes]
Patient health questionnaire 15 (PHQ 15): a 15 item questionnaire (0 to 30 points, higher values indicating more somatic symptoms)
Depression [3 minutes]
Patient health questionnaire 9 (PHQ 9): a 9 item questionnaire (0 to 27 points, higher values indicating more depressive symptoms)
Psychosomatic Competence [up to 10 minutes]
Psychosomatic Competence Inventory (PSCI): a 44 items questionnaire with a 6 point Likert scale, resulting in 6 subscales, higher values indicate higher psychosomatic competence
Work ability [5 minutes]
Work ability index (WAI): 7 item questionnaire, 7 to 49 points, with higher values indicating better work ability
Trauma in childhood [up to 10 minutes]
Child Trauma Questionnaire (CTQ): 28 items questionnaire, 5 point Likert scale, resulting in 5 subscales with 5 to 25 points, with higher values indicating more trauma experience
Attachment styles [5 minutes]
Experience of Close Relationships-Revised (ECR-RD 12): 12 items questionnaire with a 7 point Likert scale, resulting in 2 subscales
Alexithymia [5 minutes]
Toronto alexithymia scale (TAS): 26 items questionnaire with a 5 point Likert scale, higher values indicating more alexithymia
Personality traits [up to 10 minutes]
The Personality Inventory for DSM-5 and ICD-11 Plus Modified (PID5BF + M): a 36 items questionnaire, with a 4 point Likert scale, resulting in 6 subscales
Personality functioning [up to 15 minutes]
Levels of personality functioning scale (LPFS): a 80 items questionnaire, with a 4 point Likert scale, resulting in 4 subscales
Executive function [up to 10 minutes]
Comprehensive trail making test (CTMT)
Memory [up to 15 minutes]
Wechsler Memory Scale
Visuospatial abilities [up to 15 minutes]
Rey-Osterrieth complex figure test
Functional cognitive symptoms [up to 60 minutes]
Incongruence in cognitive tests
Semantic word fluency [2 minutes]
number of animals that can be listed in 2 minutes
phonematic word fluency [2 minutes]
number of words, that start with the letter "b", that can be listed in 2 minutes