Observational Study on "Functional Overlay" in Patients With Movement Disorders
- Conditions
- TremorDystoniaConversion DisorderParkinson Disease
- Interventions
- Diagnostic Test: Neurological examinationDiagnostic Test: AnamnesisDiagnostic Test: Neuropsychological testingDiagnostic Test: QuestionnairesDiagnostic Test: Tremor recording
- Registration Number
- NCT05943652
- Lead Sponsor
- Medical University of Graz
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
- Functional or non-functional movement disorder
- 18 to 80 years
- Patient is not able to consent
- Patient is not able to understand / speak German fluently (questionnaires are available only in German)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson Disease Neurological examination - Parkinson Disease Neuropsychological testing - Parkinson Disease Questionnaires - Functional Neurological Disorder Anamnesis - Essential Tremor Neurological examination - Parkinson Disease Anamnesis - Idiopathic Dystonia Neurological examination - Idiopathic Dystonia Tremor recording - Essential Tremor Tremor recording - Parkinson Disease Tremor recording - Essential Tremor Anamnesis - Essential Tremor Questionnaires - Functional Cognitive Disorder Neurological examination - Alzheimer Disease Neurological examination - Idiopathic Dystonia Anamnesis - Idiopathic Dystonia Questionnaires - Functional Cognitive Disorder Neuropsychological testing - Functional Cognitive Disorder Tremor recording - Idiopathic Dystonia Neuropsychological testing - Functional Neurological Disorder Neuropsychological testing - Functional Neurological Disorder Questionnaires - Alzheimer Disease Anamnesis - Alzheimer Disease Neuropsychological testing - Alzheimer Disease Tremor recording - Essential Tremor Neuropsychological testing - Functional Neurological Disorder Neurological examination - Functional Cognitive Disorder Questionnaires - Functional Cognitive Disorder Anamnesis - Functional Neurological Disorder Tremor recording - Alzheimer Disease Questionnaires -
- Primary Outcome Measures
Name Time Method Functional neurological symptoms on average 30 minutes Diagnosed by positive signs for functional neurological symptoms, as assessed in the neurological examination
- Secondary Outcome Measures
Name Time Method 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
Visuospatial abilities up to 15 minutes Rey-Osterrieth complex figure test
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
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)
Work ability 5 minutes Work ability index (WAI): 7 item questionnaire, 7 to 49 points, with higher values indicating better work ability
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
Fatigue up to 5 minutes Fatigue severity scale (FSS): 9 item questionnaire with a 7 point Likert scale, higher values indicating more fatigue
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?"
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
Depression 3 minutes Patient health questionnaire 9 (PHQ 9): a 9 item questionnaire (0 to 27 points, higher values indicating more depressive symptoms)
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
Executive function up to 10 minutes Comprehensive trail making test (CTMT)
Memory up to 15 minutes Wechsler Memory Scale
phonematic word fluency 2 minutes number of words, that start with the letter "b", that can be listed in 2 minutes
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
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 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
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
Trial Locations
- Locations (1)
Medical University of graz
🇦🇹Graz, Styria, Austria