Trial document




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  DRKS00014181

Trial Description

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Title

Symptom-guided treatment influences brain plasticity - Neurofeedback-based training in patients with psychomotoric affective symptoms

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Trial Acronym

APIC-PNF

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URL of the Trial

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Brief Summary in Lay Language

The MRI technology is a non-invasive method, i.e., it is completely harmless to the body according to the current state of knowledge. This particular study is designed to learn conscious self-control of the activity in brain regions that are important for motivation and action. Our goal is for the participants to learn how to regulate this activity by neurofeedback during the study. The study is aimed towards patients with depression and schizophrenia as well as healthy participants.
Neurofeedback is a computer-aided training method that makes a subject's own brain activity perceptible to a selected region. It investigates how conscious control of these areas affects your mood. In the long run, a conscious self-control of this activity could help you in everyday life to find strategies to deal better with negatively charged stimuli or situations.

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Brief Summary in Scientific Language

The aim of the study is to investigate brain plasticity after neuromodulation with fMRT neurofeedback in affective symptoms. Target groups are patients with depressive disorders as well as patients with schizophrenia. During fMRI neurofeedback training, subjects should learn to consciously regulate the activity of areas associated with motivation and action. The aim is to improve the subjectively perceived emotional perception in everyday life of the patients as well as to investigate the effect of the therapy method on resting networks in the brain. As a control group healthy volunteers will be examined.

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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

  •   DRKS00014181
  •   2018/03/07
  •   [---]*
  •   yes
  •   Approved
  •   EK 188/17, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F31.3 -  Bipolar affective disorder, current episode mild or moderate depression
  •   F34 -  Persistent mood [affective] disorders
  •   F20 -  Schizophrenia
  •   F21 -  Schizotypal disorder
  •   F22 -  Persistent delusional disorders
  •   F23 -  Acute and transient psychotic disorders
  •   F24 -  Induced delusional disorder
  •   F25 -  Schizoaffective disorders
  •   F28 -  Other nonorganic psychotic disorders
  •   F29 -  Unspecified nonorganic psychosis
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Interventions/Observational Groups

  •   Neurofeedback training in patients with depression according to the ICD-10 criteria: F32.x, F33.x, F31.3 or F34.x.
    Neurofeedback training: Participants will be trained in cognitive regulation of the "supplementary motor area" using our virtual reality platform. They will receive perceivable visual feedback of the performance of their cognitive activity. They will be able to use this feedback to improve their cognitive regulation.
  •   Neurofeedback training of SMA up- versus down-regulation in patients with schizophrenic disorder according to ICD-10: F2x
  •   Neurofeedback training of SMA up- versus down-regulation in matched healthy controls
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Other
  •   Treatment
  •   Crossover
  •   I-II
  •   N/A
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Primary Outcome

The effect of neurofeedback training on apathy (lack of motivation) in patients diagnosed with depression will be assessed using the self-reported Apathy Evaluation Scale (AES) questionnaire. The participants will fill out the AES on the first day of enrollment. Following this day, on two other days a neurofeedback training will be performed using fMRI. The two measurement days in the cross-over design will be separated by a week. After the final day of training, we will issue another AES questionnaire to the participant. Following this, there will be a follow up day, approximately four weeks after the second measurement. On the follow up day, we will again issue the AES.
We will assess the effect our neurofeedback training paradigm had on the brain activity of the supplementary motor area (SMA) measured by fMRI. And how this change in SMA activity influences apathy in depressive patients.

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Secondary Outcome

The effect of neurofeedback training on impulsivity in patients diagnosed with depression will be assessed using reaction times as measured by a Go-NoGo task. After the first day of enrollment, neurofeedback training will be performed using fMRI, on two more days. The two measurement days will be separated by a week. On each day there will be three neurofeedback training sessions during the measurement. Reaction times will be measured before the first session, then in between the next two sessions and also after the last session. The same will be repeated on the second measurement day.
It will be assessed the effect of our neurofeedback training paradigm on the brain activity of the supplementary motor area (SMA), measured by fMRI. And how this change in SMA activity influences impulsivity in depressive patients.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/03/11
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Inclusion criteria for all participants:
- Age: 18 - 75 years,
- good knowledge of German.

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Exclusion Criteria

Exclusion criteria for all participants:
- pregnancy or nursing period,
- contraindications to MR examinations, such as magnetic metal implants, large-scale tattoos or claustrophobia,
- Participants or patients that are not able to consent to the study

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Addresses

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    • Universitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Prof  Klaus  Mathiak 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Prof  Klaus  Mathiak 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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