Clinical trial NCT05943652: Observational Study on "Functional Overlay" in Patients With Movement Disorders
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Conversion Disorder
Parkinson Disease
Tremor
Dystonia
Keywords: Accelerometry
Patient Health Questionnaire
Neuropsychology
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with functional and non-functional movement disorders of the Movement Disorders Outpatient Clinic of the Department of Neurology, 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional neurological symptoms
timeFrame: on average 30 minutes
Secondary outcomes:
measure: Duration of anamnesis
timeFrame: 1 to 3 minutes
measure: Tremor diagnostic
timeFrame: up to 20 minutes
measure: Subjective quality of life
timeFrame: 5 minutes
measure: Subjective health
timeFrame: up to 10 minutes
measure: Fatigue
timeFrame: up to 5 minutes
measure: General anxiety
timeFrame: 3 minutes
measure: Somatic symptoms
timeFrame: 5 minutes
measure: Depression
timeFrame: 3 minutes
measure: Psychosomatic Competence
timeFrame: up to 10 minutes
measure: Work ability
timeFrame: 5 minutes
measure: Trauma in childhood
timeFrame: up to 10 minutes
measure: Attachment styles
timeFrame: 5 minutes
measure: Alexithymia
timeFrame: 5 minutes
measure: Personality traits
timeFrame: up to 10 minutes
measure: Personality functioning
timeFrame: up to 15 minutes
measure: Executive function
timeFrame: up to 10 minutes
measure: Memory
timeFrame: up to 15 minutes
measure: Visuospatial abilities
timeFrame: up to 15 minutes
measure: Functional cognitive symptoms
timeFrame: up to 60 minutes
measure: Semantic word fluency
timeFrame: 2 minutes
measure: phonematic word fluency
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of graz
state: Styria
Study officials:
References: