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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943652
• Other study ID #: 34-509 ex 21/22
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Medical University of Graz
• Contact: Daniela Kern, MD
• Phone: 004331638516051
• Email: daniela.eibl[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Dystonia
• Movement Disorders
• Parkinson Disease
• Tremor

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Austria	Medical University of graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional neurological symptoms	Diagnosed by positive signs for functional neurological symptoms, as assessed in the neurological examination	on average 30 minutes
Secondary	Duration of anamnesis	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
Secondary	Tremor diagnostic	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
Secondary	Subjective quality of life	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
Secondary	Subjective health	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
Secondary	Fatigue	Fatigue severity scale (FSS): 9 item questionnaire with a 7 point Likert scale, higher values indicating more fatigue	up to 5 minutes
Secondary	General anxiety	General anxiety disorder scale 7 (GAD-7): a 7 items questionnaire (0 to 21 points, higher values indicating more anxiety)	3 minutes
Secondary	Somatic symptoms	Patient health questionnaire 15 (PHQ 15): a 15 item questionnaire (0 to 30 points, higher values indicating more somatic symptoms)	5 minutes
Secondary	Depression	Patient health questionnaire 9 (PHQ 9): a 9 item questionnaire (0 to 27 points, higher values indicating more depressive symptoms)	3 minutes
Secondary	Psychosomatic Competence	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
Secondary	Work ability	Work ability index (WAI): 7 item questionnaire, 7 to 49 points, with higher values indicating better work ability	5 minutes
Secondary	Trauma in childhood	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
Secondary	Attachment styles	Experience of Close Relationships-Revised (ECR-RD 12): 12 items questionnaire with a 7 point Likert scale, resulting in 2 subscales	5 minutes
Secondary	Alexithymia	Toronto alexithymia scale (TAS): 26 items questionnaire with a 5 point Likert scale, higher values indicating more alexithymia	5 minutes
Secondary	Personality traits	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
Secondary	Personality functioning	Levels of personality functioning scale (LPFS): a 80 items questionnaire, with a 4 point Likert scale, resulting in 4 subscales	up to 15 minutes
Secondary	Executive function	Comprehensive trail making test (CTMT)	up to 10 minutes
Secondary	Memory	Wechsler Memory Scale	up to 15 minutes
Secondary	Visuospatial abilities	Rey-Osterrieth complex figure test	up to 15 minutes
Secondary	Functional cognitive symptoms	Incongruence in cognitive tests	up to 60 minutes
Secondary	Semantic word fluency	number of animals that can be listed in 2 minutes	2 minutes
Secondary	phonematic word fluency	number of words, that start with the letter "b", that can be listed in 2 minutes	2 minutes