Trial document




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  DRKS00003287

Trial Description

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Title

Characteristics and Training of Neural Responding in BPD

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Trial Acronym

[---]*

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URL of the Trial

http://www.kfo256.de/de/forschung/emotionale-reize-und-neurofeedback.html

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Brief Summary in Lay Language

Patients suffeirng form borderline personality disorder will be undergo a special magnetic resonance imaging investigation. They will see pictures with pleasurable and unpleasurable content. Furtehrmore, patients will be trained to specifically influence their reaction to those pictures. The aim is to investigate whether this approach could be used therapeutically.

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Brief Summary in Scientific Language

Patients with BPD suffer from intense emotions and emotion dysregulation, which is strongly related to dysfunctional behavior. Besides the convincing success of imaging tools in research, there is a yet unmet demand for new options in the individual treatment of BPD patients. The concept of fMRI-based neurofeedback might bridge this gap and make real-time fMRI a therapeutic option. Previous research at the behavioral and physiological level revealed stronger emotional responses as well as rapidly increasing and slowly decreasing emotional responses in patients with BPD. Given the results at the behavioral and physiological level pointing to differences in the time course of emotional responding in BPD, it seems important to supply this information for the neural level. However, to our knowledge, all studies reporting increased activity in limbic regions in BPD used standard models of the Hemodynamic Response Function (HRF) and there are no studies investigating the effective course of neural responding in BPD by, for example, identifying the amplitude of the event-related BOLD-response in different brain regions. Therefore, the first aim of this project is to determine the latency, peak, and time course of the blood oxygenation level-dependent (BOLD) response in different brain regions in BPD using negative and neutral visual stimuli. We expect a higher and more prolonged event-related BOLD response in the amygdala and insula in BPD. In a second step, we want to use the attained evidence to develop a real-time fMRI-based neurofeedback training for BPD. Neurofeedback will be used to enable patients to regulate their brain activity for therapeutic purposes. We assume that it will be favourable to train patients to influence their neural activity (i.e. by down-regulating limbic hyperactivity). Results of this study may help to improve treatment of emotion dysregulation in BPD.

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Organizational Data

  •   DRKS00003287
  •   2011/11/18
  •   [---]*
  •   yes
  •   Approved
  •   2011-224N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   F60.31 -  [generalization F60.3: Emotionally unstable personality disorder]
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Interventions/Observational Groups

  •   Characterisation of neural response: 20 female patients with BPD
    Neurofeedback training: 20 female patients with BPD
    -In the first trial arm, 20 patients with BPD will be included. First, before the first measurement, diagnostic measures of axis 1 and 2 disorders will be obtained. BPD diagnosis will be obtained with the international personality disorder examination (IPDE), symptom severity will be measured with the borderline symptom list (BSL-95, Bohus et al. 2007). If inclusion criteria are met and informed consent is obtained, the participant will be included in the study.
  •   Subprojekt1 (chracterisation of neuronal response):
    20 remitted female patients
  •   Characterisation of neural response:
    20 female healthy controls
    Neurofeedback training:
    40 female healthy controls
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Characteristics

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

The BOLD response assessed with fMRI will be explored and better characterized. This should enhance the separation between healthy controls and BPD patients

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Secondary Outcome

We will test the hypothesis that BPD patients are able to learn to control their emotional response by an fMRI neurofeedback training.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/23
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

1. Diagnosis of BPD following DSM4.
2. Remitted patients need to fullfill less than 5 DSM4criteria.
3. Healthy controls aged 18-45 without a history of psychiatric disorders.

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Exclusion Criteria

Exclusion criteria for all participants
• Pregnancy
• Lifetime diagnosis of psychotic disorder or bipolar I disorder
• Major depressive episode at the time of measurement
• Substance dependency in the preceding year
• Organic brain diseases
• Severe medical or neurological condition
• Antecedent cranial or brain injuries
• Metallic items in or on the body
• Left-handedness
• Claustrophobia
- Chronic non-healing wounds
- blood coagulation disorder
- medication with marcumar
- anamnestic brain lesion
- psychotropic medication within the last two weeks


Additional criteria for the healthy control group:
• Fulfilling more than one DSM IV criterion for BPD
• Any psychiatric disease

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health
    • Mr.  Prof. (apl.) Dr. med.  Christian  Schmahl 
    • J 5
    • 68159  Mannheim
    • Germany
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    • Department Neuroimaging, Central Institute of Mental Health
    • Ms.  Prof. (apl.) Dr. Dipl.-Phys.  Gabriele  Ende 
    • J5
    • 68159  Mannheim
    • Germany
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    • Central Institute of Mental Health
    • Mr.  Christian  Paret 
    • J5
    • 68159  Mannheim
    • 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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    • Haushaltsmittel
    • Zentralinstitut für seel. Gesundheit / J5
    • 68159  Mannheim
    • 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.