Trial document





This trial has been registered retrospectively.
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  DRKS00007139

Trial Description

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Title

The significance of adverse experience, emotional processing and body perception for
functional (pseudo-) neurological symptoms: A longitudinal study (pre-post-comparison)

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Trial Acronym

[---]*

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URL of the Trial

http://www.psychologie.uni-konstanz.de/forschung/clinicalpsychology/projekte/pseudoneurologische-symptome/

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Brief Summary in Lay Language

Neurological symptoms (such as movement-, sensibility- or sight-disorders) without neurologically determined origin are called pseudoneurological symptoms (PNS) in ICD-10 and functional neurological symptoms (FNS) in DSM-5. A high risk for chronicity,psychological strain and consequent burden on the health system define their clinical relevance.
However, treatment outcome is insufficient, which can be partly attributed to insufficient diagnostic and etiological clarity. With the overall long-term goal to contribute to more precise assessment of FNS the primary goal of the planned project is to examine the hypothetical model that FNS, characterized as somatoform dissociation, results from an interplay of (early, predominantly) emotional adversities and abuse, with subsequent disconnection of emotional and biological systems. An imbalance in emotion processing towards alexithymia and habitual emotion
suppression augments attentional focus on interoception, particularly following emotional stress.
We will examine this model in a series of studies including (1) self-assessment (questionnaires,
interview), (2) psychophysiological and behavioral experiments (addressing cortical correlates of automatic responses to emotional stimuli and emotion regulation, and examining exteroceptive threshold upon modulation of interoceptive focus of attention) pre and post psychotherapeutical inpatient treatment.

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Brief Summary in Scientific Language

Neurological symptoms (such as movement-, sensibility- or sight-disorders) without neurologically determined origin are called pseudoneurological symptoms (PNS) in ICD-10 and functional neurological symptoms (FNS) in DSM-5. A high risk for chronicity,psychological strain and consequent burden on the health system define their clinical relevance.
However, treatment outcome is insufficient, which can be partly attributed to insufficient diagnostic and etiological clarity. With the overall long-term goal to contribute to more precise assessment of FNS the primary goal of the planned project is to examine the hypothetical model that FNS, characterized as somatoform dissociation, results from an interplay of (early, predominantly) emotional adversities and abuse, with subsequent disconnection of emotional and biological systems. An imbalance in emotion processing towards alexithymia and habitual emotion
suppression augments attentional focus on interoception, particularly following emotional stress.
We will examine this model in a series of studies including (1) self-assessment (questionnaires,
interview), (2) psychophysiological and behavioral experiments (addressing electrocortical correlates of automatic responses to emotional stimuli and emotion regulation, and examining exteroceptive threshold upon modulation of interoceptive focus of attention) pre and post psychotherapeutical inpatient treatment.

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Organizational Data

  •   DRKS00007139
  •   2015/08/19
  •   [---]*
  •   yes
  •   Approved
  •   EK vergibt keine Nummern, Ethik-Kommission der Universität Konstanz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F44 -  Dissociative [conversion] disorders
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Interventions/Observational Groups

  •   The "Experimental Group": n=30 patients with at least one negative functional neurological symptom, diagnosed with a dissociative disorder.
    All patients are inpatients in a neurological rehabilitation center at the Department of Psychotherapeutical Neurology and receive psychotherapeutical, physiotherapeutic and medical treatment.
    No active intervention.

    Two times of measurement at the beginning and at the end of the patients' stay with
    (A) Standardized questions about their symptoms (SDQ-20, DES, SCL90R, SOMS, BDI, PDS), emotion processing (TAS-26, ERQ) and adverse experience (PDS, KERF, ETI) accompanied by body sensitivity measurements using transcutaneous electrical nerve stimulation (=TENS).
    (B) Experimental measurement of emotion processing while recording and EEG/MEG (for measuring cortical alpha-desynchronisation), accompanied by body sensitivity measurements using TENS.
  •   The "Neurological Control Group": n=30 patients with at least one neurological and a comorbid psychiatric symptom.

    All patients are inpatients in a neurological rehabilitation center at the Department of Psychotherapeutical Neurology and receive psychotherapeutical, physiotherapeutic and medical treatment.

    No active intervention.

    Two times of measurement at the beginning and at the end of the patients' stay with
    (A) Standardized questions about their symptoms (SDQ-20, DES, SCL90R, SOMS, BDI, PDS), emotion processing (TAS-26, ERQ) and adverse experience (PDS, KERF, ETI) accompanied by body sensitivity measurements using transcutaneous electrical nerve stimulation (=TENS).
    (B) Experimental measurement of emotion processing while recording and EEG/MEG (for measuring cortical alpha-desynchronisation), accompanied by body sensitivity measurements using TENS.
  •   The "Healthy Comparison Group" (n=30) does not receive any intervention.

    Two times at intervals of 4-6 weeks with
    (A) Standardized questions about their symptoms (SDQ-20, DES, SCL90R, SOMS, BDI, PDS), emotion processing (TAS-26, ERQ) and adverse experience (PDS, KERF, ETI) accompanied by body sensitivity measurements using transcutaneous electrical nerve stimulation (=TENS).
    (B) Experimental measurement of emotion processing while recording and EEG/MEG (for measuring cortical alpha-desynchronisation), accompanied by body sensitivity measurements using TENS.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Two times of measurement at the beginning and at the end of the patients' stay respectively at intervals of 4-6 weeks (healthy comparison group) with
(A) Standardized questions about their symptoms (SDQ-20, DES, SCL90R, SOMS, BDI, PDS), emotion processing (TAS-26, ERQ) and adverse experience (PDS, KERF, ETI) accompanied by body sensitivity measurements using transcutaneous electrical nerve stimulation (=TENS).
(B) Experimental measurement of emotion processing while recording and EEG/MEG (for measuring cortical alpha-desynchronisation), accompanied by body sensitivity measurements using TENS.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/07/13
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Experimental FNS Group:
At least one negative somatoform functional neurological symptom and diagnosed with a dissociative disorder by at least two neurologists / psychiatrists.
Neurological Control Group:
At least one neurological symptom and one psychiatric symptom, similar treatment / inpatient on the same ward.

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Exclusion Criteria

Experimental FNS Group:
Positive somatoform functional neurological symptoms, central lesions or other central nervous illnesses
Neurological Control Group:
FNS /dissociative disorder
Healthy Comparison Group:
Neurological or psychiatric treatment and/or diagnosis in M.I.N.I. Psychiatric Screening

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Addresses

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    • Universität Konstanz
    • Ms.  Dr.  Astrid  Steffen 
    • Postfach 905
    • 78457  Konstanz
    • Germany
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    • Universität Konstanz
    • Ms.  Dr.  Astrid  Steffen 
    • Postfach 905
    • 78457  Konstanz
    • Germany
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    • Universität Konstanz
    • Ms.  Dr.  Astrid  Steffen 
    • Postfach 905
    • 78457  Konstanz
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Ausschuss für Forschungsfragen der Universität Konstanz
    • Universitätsstraße 10
    • 78464  Konstanz
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.