Neurofeedback in Adolescents With Emotion Dysregulation (EFPTest)

March 4, 2022 updated by: Christian Paret, Central Institute of Mental Health, Mannheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68159
        • Central Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EFP 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.
Behavioral: neurofeedback
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.
No Intervention: Treatment as usual
Like patients from the treatment arm, these patients are on current residential treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amygdala self-regulation
Time Frame: 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.
Change from baseline to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alexithymia
Time Frame: 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)
Change from baseline to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: Paret, Central Institute of Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-519N-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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