- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05943652
Observational Study on "Functional Overlay" in Patients With Movement Disorders
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
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Daniela Kern, MD
- Phone Number: 004331638516051
- Email: daniela.eibl@medunigraz.at
Study Contact Backup
- Name: Petra Schwingenschuh, MD
- Phone Number: 004331638583379
- Email: petra.schwingenschuh@medunigraz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8010
- Recruiting
- Medical University of Graz
-
Contact:
- Daniela Kern, MD
- Phone Number: 004331638516051
- Email: daniela.eibl@medunigraz.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Functional or non-functional movement disorder
- 18 to 80 years
Exclusion Criteria:
- Patient is not able to consent
- Patient is not able to understand / speak German fluently (questionnaires are available only in German)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parkinson Disease
|
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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 cognitive testing including:
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
|
|
Idiopathic Dystonia
|
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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 cognitive testing including:
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
|
|
Essential Tremor
|
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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 cognitive testing including:
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
|
|
Functional Neurological Disorder
|
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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 cognitive testing including:
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
|
|
Functional Cognitive Disorder
|
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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 cognitive testing including:
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
|
|
Alzheimer Disease
|
A neurological examination following a protocol to detect positive signs of functional neurological disorders.
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 cognitive testing including:
Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional neurological symptoms
Time Frame: on average 30 minutes
|
Diagnosed by positive signs for functional neurological symptoms, as assessed in the neurological examination
|
on average 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of anamnesis
Time Frame: 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?"
|
1 to 3 minutes
|
|
Tremor diagnostic
Time Frame: 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
|
up to 20 minutes
|
|
Subjective quality of life
Time Frame: 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
|
5 minutes
|
|
Subjective health
Time Frame: 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
|
up to 10 minutes
|
|
Fatigue
Time Frame: up to 5 minutes
|
Fatigue severity scale (FSS): 9 item questionnaire with a 7 point Likert scale, higher values indicating more fatigue
|
up to 5 minutes
|
|
General anxiety
Time Frame: 3 minutes
|
General anxiety disorder scale 7 (GAD-7): a 7 items questionnaire (0 to 21 points, higher values indicating more anxiety)
|
3 minutes
|
|
Somatic symptoms
Time Frame: 5 minutes
|
Patient health questionnaire 15 (PHQ 15): a 15 item questionnaire (0 to 30 points, higher values indicating more somatic symptoms)
|
5 minutes
|
|
Depression
Time Frame: 3 minutes
|
Patient health questionnaire 9 (PHQ 9): a 9 item questionnaire (0 to 27 points, higher values indicating more depressive symptoms)
|
3 minutes
|
|
Psychosomatic Competence
Time Frame: 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
|
up to 10 minutes
|
|
Work ability
Time Frame: 5 minutes
|
Work ability index (WAI): 7 item questionnaire, 7 to 49 points, with higher values indicating better work ability
|
5 minutes
|
|
Trauma in childhood
Time Frame: 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
|
up to 10 minutes
|
|
Attachment styles
Time Frame: 5 minutes
|
Experience of Close Relationships-Revised (ECR-RD 12): 12 items questionnaire with a 7 point Likert scale, resulting in 2 subscales
|
5 minutes
|
|
Alexithymia
Time Frame: 5 minutes
|
Toronto alexithymia scale (TAS): 26 items questionnaire with a 5 point Likert scale, higher values indicating more alexithymia
|
5 minutes
|
|
Personality traits
Time Frame: 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
|
up to 10 minutes
|
|
Personality functioning
Time Frame: up to 15 minutes
|
Levels of personality functioning scale (LPFS): a 80 items questionnaire, with a 4 point Likert scale, resulting in 4 subscales
|
up to 15 minutes
|
|
Executive function
Time Frame: up to 10 minutes
|
Comprehensive trail making test (CTMT)
|
up to 10 minutes
|
|
Memory
Time Frame: up to 15 minutes
|
Wechsler Memory Scale
|
up to 15 minutes
|
|
Visuospatial abilities
Time Frame: up to 15 minutes
|
Rey-Osterrieth complex figure test
|
up to 15 minutes
|
|
Functional cognitive symptoms
Time Frame: up to 60 minutes
|
Incongruence in cognitive tests
|
up to 60 minutes
|
|
Semantic word fluency
Time Frame: 2 minutes
|
number of animals that can be listed in 2 minutes
|
2 minutes
|
|
phonematic word fluency
Time Frame: 2 minutes
|
number of words, that start with the letter "b", that can be listed in 2 minutes
|
2 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Dyskinesias
- Somatoform Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Parkinson Disease
- Tremor
- Dystonia
- Conversion Disorder
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Neurological
- Physical Examination
- Immune System Phenomena
- Immunity
- Adaptive Immunity
- Neurologic Examination
- Immunologic Memory
Other Study ID Numbers
- 34-509 ex 21/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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