Observational Study on "Functional Overlay" in Patients With Movement Disorders
NCT ID: NCT05943652
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
216 participants
OBSERVATIONAL
2023-01-01
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Parkinson Disease
Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
Tremor recording
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Idiopathic Dystonia
Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
Tremor recording
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Essential Tremor
Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
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
Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
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
Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
Tremor recording
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Alzheimer Disease
Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
Tremor recording
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Interventions
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Neurological examination
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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?"
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
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)
Tremor recording
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
Eligibility Criteria
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Inclusion Criteria
* 18 to 80 years
Exclusion Criteria
* Patient is not able to understand / speak German fluently (questionnaires are available only in German)
18 Years
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University of graz
Graz, Styria, Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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34-509 ex 21/22
Identifier Type: -
Identifier Source: org_study_id
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