Neurofeedback in Adolescents With Emotion Dysregulation

Not Applicable

Completed

• Conditions: Emotional Disturbances
• Interventions: Behavioral: neurofeedback

• Registration Number: NCT03964545
• Lead Sponsor: Central Institute of Mental Health, Mannheim

Brief 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.

Study Timeline

• Study Start: 2018-05-14
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Primary Completion: 2021-03-30
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EFP neurofeedback	neurofeedback	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.

Primary Outcome Measures

Name	Time	Method
Amygdala self-regulation	Change from baseline to 5 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Central Institute of Mental Health; 🇩🇪 Mannheim, Germany