Neurofeedback in Adolescents With Emotion Dysregulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proof-of-concept and Validity of Amygdala-neurofeedback in Adolescent Patients With Emotion Dysregulation

Conditions
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Emotional Disturbances

Intervention / Treatment
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* Behavioral: neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients will be included with four or more BPD and/or PTSD criteria (DSM-5) Willingness to participate in the study On residential treatment at adolescence center (Central Institute of Mental Health) throughout the study, including assessment of transfer. Exclusion Criteria: General Pharmacological therapy with benzodiazepines Substance use Pregnancy Eplilepsy, traumatic brain injury, brain tumor or otherwise severe neurological or medical history BMI > 16.5 Non-removable electrical implants Non-removable ferrous metal implants Permanent make-up and tattoos Claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFP neurofeedback<br>Ten sessions of EFP neurofeedback training. EEG is picked up with scalp electrodes, processed in real-time and returned to patients. One session lasts 30 min. | Behavioral: neurofeedback<br>* 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.<br>|
| No Intervention: Treatment as usual<br>Like patients from the treatment arm, these patients are on current residential treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amygdala self-regulation | Amygdala BOLD regulation is assessed in a transfer task. Transfer task: Two 60s-blocks of BOLD fMRI neurofeedback (visual thermometer) with instruction to down-regulate. | Change from baseline to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alexithymia | Impaired cognitive processing of emotion, assessed via questionnaire TAS-26, score range: 0-130 (higher score indicates higher alexithymia) | Change from baseline to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline, Post-traumatic stress, Neurofeedback, Amygdala, Emotion regulation