Neurofeedback in Adolescents With Emotion Dysregulation
Condition: Emotional Disturbances
MeSH terms: Affective Symptoms
Study type: Interventional

Summary: 
      A treatment to improve emotion regulation is tested in young patients with trauma-related
      mental disorder. The Electrical FingerPrint (EFP) from the amygdala is used for presenting
      patients with feedback (i.e. neurofeedback) from the amygdala, a brain region which plays a
      critical role in emotion and mental disorder. Via feedback, patients learn to self-regulate
      the neural circuit of emotion.
    

Detailed description: 
      The study tests a neurofeedback treatment for emotion regulation training in adolescent
      patients suffering from emotional disturbances, indicated by diagnosis with borderline
      personality disorder (BPD) and/or post-traumatic stress disorder (PTSD), using innovative
      Electric Finger-Print (EFP) technology. With neurofeedback, patients can learn to regulate
      brain activation from emotion brain circuit. The technique allows neurofeedback training of
      sub-cortical brain activation outside the brain scanner, using an electroencephalography
      (EEG) surrogate of amygdala activation. The novel approach combines the advantages of
      functional magnetic resonance imaging (fMRI, i.e. high spatial resolution) and EEG (high
      scalability). EFP allows the probing of deep brain signals with scalp-electrodes, thus
      bridging a technological gap in neurofeedback training. The developers used EEG feature
      extraction and machine learning to receive model coefficients (i.e. the EFP) predicting
      amygdala BOLD activation based on EEG-channel activity (see Citations in this registration).

      Participation in this trial is offered to patients who receive residential treatment at the
      adolescence center of the Central Institute of Mental Health (Mannheim, Germany) to obtain
      proof-of-concept in this special population, and to show potential value of adjuvant
      neurofeedback treatment. Patients in the treatment group receive 10 neurofeedback sessions
      within 5 weeks. Transfer is assessed with neural and questionnaire measures afterwards. A
      treatment-as-usual (TAU) control group does not receive the neurofeedback. We expect to
      replicate correlation of EFP with the blood oxygenation level dependent (BOLD) signal from
      the amygdala, which is tested via simultaneous fMRI-EEG data acquisition post-treatment.
      Additionally, we assume improved amygdala-BOLD regulation in an fMRI neurofeedback test.

      This study aims to extend proof-of-concept of EFP neurofeedback to an adolescent population
      suffering from severe emotional disturbances.
    

Intervention name(s): neurofeedback
Intervention type(s): Behavioral
Intervention description(s): Patients are instructed to reduce amygdala activation by means of down-regulating the EFP. An auditory feedback interface is used with the instruction to down-regulate volume of a jingle, reflecting intensity of EFP.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Borderline; Post-traumatic stress; Neurofeedback; Amygdala; Emotion regulation