Trial document




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  DRKS00017557

Trial Description

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Title

Effects of near-infrared spectroscopy (NIRS) - neurofeedback on emotion regulation in patients with self-injurious behavior (SI): a pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Our aim is to find out if a specific NIRS neurofeedback training program designed by us can positively affect the behavior of adolescents with self-injurious behaviors. Adolescents will be randomly assigned to one of two groups: one group trains one, the other group trains another brain region. Both regions have already been known from other studies and have shown positive effects e.g. when beeing trained by patients with ADHD. Our goal is to examine the effectiveness of both training approaches. The study procedures between the two groups will not differ, so that it will not be clear to the subject in which group she is. We will measure the effectiveness by measuring differences pre-post using fMRI and psychometric Tests as well as by measuring cortisol and oxytocin levels in saliva.

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Brief Summary in Scientific Language

The diagnosis of Non-suicidal self-injurious (NSSI) behavior in children and adolescence include all acts and behaviors of conscious self-harm, without suicidal intention. Epidemiological studies estimate the lifetime prevalence of NSSI in adolescence at around 13 to 25 percent and the estimated number of patients with NSSI in psychiatric-clinical samples is much higher.

With such a high prevalence rate and high comorbidity rates of NSSI, our study arises from the need for further treatment-oriented therapie research. Untreated NSSI in adolescence is still associated with high risk for later development of severe psychiatric disorders, such as borderline personality disorder, addictions and suicidality.

The investigation of Neurofeedback as a therapeutic approach also includes the option of early intervention to prevent disease progression or transition, hence justifying the choice of adolescent subjects as study population.

Most models for the nosological classification of self-injurious behavior postulate a disturbed emotion regulation and stress processing with corresponding correlates in imaging as the underlying main etiological factor. In the current study, two alternative neurofeedback training interventions using near-infrared spectroscopy (NIRS) to improve the (emotional) self-regulatory ability of our young index group (age range 12-17) with NSSI will be tested. Possible therapeutic effects are examined by obtaining imaging, physiological and test psychological parameters before and after the intervention.

Taken together, our non-invasive proof-of-concept study, the first neurofeedback intervention in children and adolescents with NSSI, examines a new approach to therapy, and should thus contribute to the expansion of therapeutic options for young NSSI patients.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017557
  •   2019/07/08
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  •   yes
  •   Approved
  •   19-1427-101, Ethikkommission an der Universität Regensburg
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Secondary IDs

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Health Condition or Problem studied

  •   X84 -  Intentional self-harm by unspecified means
  •   Non-suicidal self-injury syndrome (DSM-5)
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Interventions/Observational Groups

  •   prefrontal neurofeedback
  •   sulcus centralis neurofeedback
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

In-between analysis between two intervention arms pre / post NIRS neurofeedback including fMRI imaging, neurophysiological and psychometric methods.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/09/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   12   Years
  •   17   Years
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Additional Inclusion Criteria

• Female
• Sufficient understanding of the German language
• right handed
• Informed consent of the study participant and their legal guardians
• Self-injurious behavior according to the diagnostic criteria of the DSM-V classification (at least five times self-harm without suicidal intention in the past year)
• Age at baseline: 12-17 years
• Treatment at the KJP Regensburg

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Exclusion Criteria

• Additional neurological or medical conditions that are believed to influence brain development / physiology
• Pre-existing neurological or endocrine disease
• Taking glucocorticoid-containing medications
• Pregnancy
• intellectual impairment (IQ <80)
• Acute psychotic disorder or acute psychiatric condition, which could affect the ability of patients / volunteers to consent
• acute suicidality
• lack of consent
• MRI-specific contraindications: metallic foreign bodies, tattoos with metallic pigments, claustrophobia, cardiac pacemakers and defibrillator systems, cochlear implants, implanted insulin pumps, non-removable magnetic material piercings.

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Addresses

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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med.  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med.  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address scientific-contact
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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med.  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
    • Mr.  Prof. Dr. med.  Romuald  Brunner 
    • Universitätsstr. 84
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting planned
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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.