Health TrialsbyHealthPanel

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

ConditionsConversion DisorderParkinson DiseaseTremorDystonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Functional or non-functional movement disorder

18 to 80 years

Disqualifiers

Patient is not able to consent

Patient is not able to understand / speak German fluently (questionnaires are available only in German)

Trial population

Patients with functional and non-functional movement disorders of the Movement Disorders Outpatient Clinic of the Department of Neurology, Medical University of Graz

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Neurological examination

    Diagnostic test

    A neurological examination following a protocol to detect positive signs of functional neurological disorders.

  • Anamnesis

    Diagnostic test

    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

    Diagnostic test

    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

    Diagnostic test

    * 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

    Diagnostic test

    Accelerometry following a standardized protocol, using a triaxial accelerometer transducer (Biometrics ACL300, Sensitivity 6 100 mV/G, Biometrics Ltd, UK)

Treatment groups

216 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Parkinson Disease5 interventions
Group B: Idiopathic Dystonia5 interventions
Group C: Essential Tremor5 interventions
Group D: Functional Neurological Disorder5 interventions
Group E: Functional Cognitive Disorder5 interventions
Group F: Alzheimer Disease5 interventions

Trial outcomes

Primary outcomes

1

Functional neurological symptoms

Diagnosed by positive signs for functional neurological symptoms, as assessed in the neurological examination

Time frame
on average 30 minutes

Secondary outcomes

1

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?"

Time frame
1 to 3 minutes
2

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

Time frame
up to 20 minutes
3

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

Time frame
5 minutes
4

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

Time frame
up to 10 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Graz

Lead sponsor

Source ClinicalTrials.gov
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